Unusual Options Activity Fri 8/25/23

The following options are exhibiting notable trading, potentially indicating changing sentiment toward the underlying stocks, and/or potentially representing positioning for increased volatility.

Bullish Call Activity:

⦁ KHC Weekly Aug25 34 calls (volume: 12.9K, open int: 300, implied vol: ~30%, prev day implied vol: 20%). 1240 contracts traded in a single transaction. Co is expected to report earnings early November.

⦁ ALKS Nov 29 calls (volume: 1510, open int: 0, implied vol: ~48%, prev day implied vol: 39%). 1500 contracts traded in a single transaction. Sarissa Capital lowers active stake to 4.997% following the sale of more than 5.7 min shares (7/27-8/24 transaction dates). Co is expected to report earnings late October.

Bearish Put Activity:

⦁ PLTR  Weekly Aug25 14 puts (volume: 35.0K, open int: 23.8K, implied vol: ~125%, prev day implied vol: 72%). 1900 contracts traded in a single transaction. Co is expected to report earnings early November,

⦁ SPWR Weekly Aug25 7 puts (volume: 3870, open int: 620, implied vol: ~102%, prev day implied vol: 74%). Co is expected to report earnings early November.

⦁ SPWH Sep 5 puts (volume: 2200, open int: 210, implied vol: ~62%, prev day implied vol: 51%). Co is confirmed to report earnings September 6 before the open.

Sentiment: The CBOE Put/Call ratio is currently: 1.12, VIX: (16.17, -1.03, -6.0%).

September 15 is options expiration -- the last day to trade September equity options.

=Alkermes (ALKS) : FDA has accepted for review the NDA for ALKS 5461

Alkermes announces that the FDA has accepted for review the NDA for ALKS 5461 for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies 

• FDA's acceptance of the ALKS 5461 NDA and rescission of the Refusal to File letter issued March 30, 2018 follows productive interactions with the Agency in which Alkermes clarified certain aspects of the NDA submission. No additional data or analyses were submitted by Alkermes to FDA.
• FDA's target action date for the ALKS 5461 NDA is Jan. 31, 2019.

-=Alkermes (ALKS) : refusal to file letter from FDA

Alkermes receives refusal to file letter from FDA for ALKS 5461  

• Co announced that it received a Refusal to File letter from the FDA regarding its New Drug Application for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies.
• Upon its preliminary review, the FDA has taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461. In addition, FDA has requested the conduct of a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.

=Alkermes (ALKS) reported earnings on Thur 27 April 2017 (b/o)

Alkermes misses by $0.09, misses on revs :

• Reports Q1 (Mar) loss of $0.18 per share, $0.09 worse than the Capital IQ Consensus of ($0.09); revenues rose 22.3% year/year to $191.8 mln vs the $195.79 mln Capital IQ Consensus.
  • Net sales of VIVITROL were $58.5 million, compared to $43.8 million for the same period in the prior year, representing an increase of approximately 33.4%.
  • Net sales of ARISTADA were $18.0 million, compared to $5.5 million for the same period in the prior year.
  • Manufacturing and royalty revenues from RISPERDAL CONSTA, INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA were $60.0 million, compared to $54.7 million for the same period in the prior year.
  • Manufacturing and royalty revenues from AMPYRA/FAMPYRA were $29.2 million, compared to $28.2 million for the same period in the prior year.
  • Royalty revenue from BYDUREON was $12.3 million, compared to $10.5 million for the same period in the prior year.