===Nektar Therapeutics (NKTR) sues Eli Lilly (LLY) over autoimmune disease treatment

• Aug 7 (Reuters) - Nektar Therapeutics on Monday sued Eli Lilly, accusing the drugmaker of undermining the prospects for Rezpeg, which Nektar was developing as a treatment for various autoimmune diseases. 

Nektar Therapeutics (NKTR) announced that efficacy data previously generated by Eli Lilly for rezpegaldesleukin (REZPEG) that were presented at the September 2022 EADV Congress were incorrectly calculated by Lilly

• The new and corrected data highlight the important potential of REZPEG to help patients battling atopic dermatitis (AtD), a chronic skin condition that afflicts nearly 10% of Americans. Specifically, the new and corrected data from the atopic dermatitis study demonstrate that 12 weeks of REZPEG therapy at the highest dose resulted in a mean Eczema Area and Severity Index (EASI) score improvement of 83% with a p-value of 0.002 as compared to placebo and an EASI-75 response rate of 41%.
• REZPEG also provided a more rapid and steep drop in EASI scores immediately after therapy initiation than the previously reported erroneous data indicated. This efficacy benefit was also maintained for 36 weeks without additional treatment after the 12-week induction period.

-=Nektar Therapeutics (NKTR) reported earnings on Thur 8 Aug 2019 (a/h)

• Reported mixed Q2 results. Co then disclosed a manufacturing issue: a suboptimal batch of in-process intermediate was used to produce two lots of bempegaldesleukin, which ultimately led to the softening of response rates in the PIVOT-02 study. The issue was restricted to the single batch of intermediates using lots two and five. Co has developed a comprehensive control strategy to limit variances in raw materials, intermediates, and the final product going forward. Downgraded at Mizuho, Jefferies, and JP Morgan. At two-year lows.
  

Nektar Therapeutics beats by $0.17, misses on revs

Reports Q2 (Jun) loss of $0.63 per share, $0.17 better than the S&P Capital IQ Consensus of ($0.80); revenues fell 97.9% year/year to $23.32 mln vs the $26.65 mln S&P Capital IQ Consensus.

"Nektar is making good progress advancing our multiple programs in immuno-oncology, immunology and pain," said Howard W. Robin, President and CEO of Nektar. "With our partner Bristol-Myers Squibb, although we've experienced some delays, we are working to finalize the development program for bempegaldesleukin in combination with nivolumab in a number of tumor types and which are designed to support registration for this unique I-O doublet. We have a number of registrational trials already started and we recently received a breakthrough designation from FDA for bempeg and nivo in the setting of first-line untreated metastatic melanoma. Our partner Eli Lilly will be initiating several new studies later this year for NKTR-358, our T regulatory stimulator candidate. These studies will expand the program with additional indications beyond lupus. We recently filed an IND with the FDA for NKTR-255, our IL-15 agonist, and will initiate our first-in-human clinical study this quarter in patients with relapsed, refractory NHL and in patients with multiple myeloma."

Nektar is hosting a conference call with analysts and investors today on which it will discuss quarterly results. On the call, the company will provide a specific update and discussion on its bempegaldesleukin clinical development program, including recent developments related to the manufacturing of bempegaldesleukin.

====Nektar Therapeutics (NKTR) : plummets on 'underwhelming' cancer trial data

• Data released Saturday suggested that patients diagnosed with melanoma aren't reacting to the company's experimental treatment as well as earlier samples did. The prior data, released last year, was in part responsible for the company's rally to all-time highs in the first half of 2018.
• Bristol-Myers Squibb, Nektar's partner on the skin cancer treatment, fell more than 3 percent Monday.

Nektar Therapeutics reports preliminary data for NKTR-214 in combination with Opdivo for patients with stage 4 metastatic melanoma, renal cell carcinoma, and urothelial cancers presented at ASCO 2018; showed that pre-specified efficacy criteria were achieved in three tumor types  

• Preliminary results from the ongoing PIVOT study presented today showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer. As a result, Nektar and Bristol-Myers Squibb (BMY) will initiate a Phase 3 registrational trial in first-line advanced melanoma patients in Q3 2018, and pivotal studies are also being designed in renal cell carcinoma and urothelial cancer.

Nektar Therapeutics (NKTR) shares dropped 29% in premarket trade Monday after the company released early data from a phase 1/2 clinical trial testing the company's NKTR-214 in combination with Bristol-Myers Squibb's (BMY) cancer drug Opdivo.

Bristol-Myers shares declined nearly 1% premarket. The trial, which tested the safety and efficacy of the combination in patients with stage IV metastatic melanoma, renal cell carcinoma and urothelial cancers, had "underwhelming" results, said EvercoreISI analyst Josh Schimmer. "We remain unconvinced that '214 adds benefit to Opdivo," he said. Noting that the companies did not separately present results for "stage 2" patients in the trial, he said, "if new cohort (N2) [overall response rate] doesn't improve substantially with follow up, we expect investors to broadly lose confidence (if they haven't already)." Drugmakers have been working to combine various cancer treatments in clinical trial to see if the combinations work better than one treatment on its own, and Bristol-Myers' Opdivo is already a blockbuster cancer drug on its own accord. Not all analysts were so gloomy about Nektar's NKTR-214, which is the company's lead immuno-oncology drug candidate and is also being tested on its own and in combination with other drugs, though the Bristol-Myers collaboration is furthest along. The latest results, presented at the American Society of Clinical Oncology's annual meeting, are "supportive of the long-term potential for NKTR-214 to enhance the efficacy of PD-1 in a number of tumor types," said J.P. Morgan analyst Jessica Fye, "but expect near-term volatility based on immature response rate data (not entirely unexpected) that came in on the low end of Street expectations" and without an update on lung cancer patients. Nektar shares have dropped 12.2% over the last three months, and Bristol-Myers shares have dropped 19.7%, compared with a 1.6% rise in the S&P 500 (SPX).

=Incyte (INCY) and Merck (MRK) : failed key Phase 3 melanoma study

• Biotech stocks (XBI) lower after important immune-oncology combo data (Incyte's IDO inhibitor plus Merck's Keytruda) fails in key Phase 3 melanoma study:  NLNK (IDO inhibitor peer) -37.57%,  INCY -18.23%,  NKTR -9.84%,  JNCE -10.20%,  LABU -5.14%,  FPRX -3.84%,  ONCS -3.72%,  SAGE -2.21%,  SGEN -1.81%,  BLUE -4.85%,  PBYI-1.85%,  SPPI -2.46%,  CRVS -9.17%,  TSRO +0.37%,  BMRN -2.01%, GLYC-2.03%, MRK-1.19% 
• IBB -1.99%,  XBI -1.78%

Incyte announces that the External Data Monitoring Committee determined that the Phase 3 ECHO-301/KEYNOTE-252 study did not meet the primary endpoint 

The co and Merck (MRK) announced that an external Data Monitoring Committee review of the pivotal Phase 3 ECHO-301/KEYNOTE-252 study results evaluating Incyte's epacadostat in combination with Merck's KEYTRUDA in patients with unresectable or metastatic melanoma determined that the study did not meet the primary endpoint of improving progression-free survival in the overall population compared to KEYTRUDA monotherapy.

• The study's second primary endpoint of overall survival also is not expected to reach statistical significance. Based on these results, and at the recommendation of the eDMC, the study will be stopped. The safety profile observed in ECHO-301/KEYNOTE-252 was consistent with that observed in previously reported studies of epacadostat in combination with KEYTRUDA.

Incyte and Merck will inform investigators of the results and work with investigators to appropriately conclude the study in a manner consistent with the best interests of each patient. Data from this study will be analyzed and submitted for presentation at an upcoming scientific congress.

-=Nektar Therapeutics (NKTR) reported earnings on Thur 1 March 2018 (a/h)

SAN FRANCISCO (AP) _ Nektar Therapeutics (NKTR) on Thursday reported a loss of $33.8 million in its fourth quarter.

The San Francisco-based company said it had a loss of 21 cents per share. Losses, adjusted for asset impairment costs, were 14 cents per share.

Nektar's stock pop followed its crushing fourth-quarter sales beat. Even without $60 million related to a nonrecurring sublicense agreement, Nektar's $95.5 million in sales still would have beat the Street's forecast for $31 million. Losses of 21 cents per share narrowed year over year and beat views for a 38-cent loss.

Analysts are also bullish on Nektar's immuno-oncology drug, NKTR-214. The drug is designed to grow cancer-killing immune cells and natural killer cells in the body to fight cancer. Last month, Nektar said it would team up with Bristol-Myers Squibb (BMY) to test NKTR-214 in regimens using Bristol's drugs.

Bristol's drugs, Opdivo and Yervoy, are also immuno-oncology compounds. Opdivo works by targeting interactions in the immune system involving the PD-1 and PD-L1 proteins. Yervoy is known as a CTLA-4 inhibitor. Combining immuno-oncology drugs is expected to offer a more potent response.

Within 14 months, Nektar and Bristol have 20 registrational studies with 15,000 patients in nine tumor types slated to begin. The first studies will be in melanoma and kidney cancer. Importantly, the deal allows Nektar to continue combinations with drugs from Dow components Merck (MRK) and Roche (RHHBY).

Canaccord analyst Arlinda Lee upped her price target on Nektar to 94 from 80 and kept her buy rating.

=Nektar Therapeutics (NKTR) signs a drug-development deal with Eli Lilly (LLY)

Nektar Therapeutics and Lilly (LLY) announce strategic collaboration to co-develop NKTR-358; Nektar will receive an initial payment of $150 mln and is eligible for up to $250 mln in additional development and regulatory milestones:

NKTR-358 is a potential first-in-class resolution therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.

• Under the terms of the agreement, Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones. Lilly and Nektar will co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development. The parties will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar. Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis. Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization. Nektar will have an option to co-promote in the U.S. under certain conditions.
• Lilly commentary on impact of transaction:
  • Subject to the closing of this transaction, Lilly expects to incur an acquired in-process research and development charge to earnings in 2017 of approximately $0.09 per share. The company's reported earnings per share guidance in 2017 is expected to be reduced by the amount of the charge. There will be no change to the company's non-GAAP earnings per share guidance as a result of this transaction.

=Nektar Therapeutics (NKTR) reported earnings on Thur 3 Nov 2016 (a/h)

Nektar Therapeutics beats by $0.04, beats on revs :

• Reports Q3 (Sep) loss of $0.32 per share, $0.04 better than the Capital IQ Consensus of ($0.36); revenues fell 39.4% year/year to $36.3 mln vs the $31.5 mln Capital IQ Consensus.
• "Our pipeline is rapidly advancing with several important data catalysts and potential approvals expected over the next several quarters," said Howard W. Robin, President and Chief Executive Officer of Nektar. "With the positive clinical results from our ongoing Phase 1 study of NKTR-214, we have now demonstrated that NKTR-214 is the first investigational medicine in immuno-oncology that selectively stimulates the in vivo proliferation of endogenous tumor-killing lymphocytes within the tumor micro-environment. In Q3, these data led to a broad clinical collaboration with Bristol-Myers Squibb to evaluate combination regimens with their anti-PD-1 agent in five different tumor types and at least seven indications. Within the next two quarters, we will have Phase 3 data for four programs: two Bayer anti-infective programs, Ophthotech's Fovista in wet AMD, and our own proprietary pain program, NKTR-181, in chronic low back pain. We are also expecting a decision from the European CHMP on conditional approval of ONZEALD by the end of Q1 2017."