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Friday, December 8, 2023

FDA Approves First Two Sickle Cell Gene Therapies

The Food and Drug Administration on Friday approved two gene therapies to treat patients with sickle cell disease, a serious genetic blood disorder most common in African-American people in the U.S.
  • The new treatments, one developed by Vertex Pharmaceuticals (VRTX) and Crispr Therapeutics (CRSP)  and the other by bluebird bio (BLUE)  are the first two gene therapies available in the U.S. for sickle cell, which the FDA says affects 100,000 people in the U.S.
  • Bluebird said it would price Lyfgenia at $3.1 million. Vertex, in a securities filing, said it would price Casgevy at $2.2 million.

Both Casgevy and Lyfgenia are made with a patient’s own blood stem cells, which must be removed and then modified. Casgevy edits the DNA of the patient’s stem cells, which are then returned to the patient, where they improve the body’s production of a particular form of hemoglobin. Lyfgenia modifies the stem cells using a viral vector approach. For both treatments, the process for patients is intensive and requires lengthy hospital stays and chemotherapy.

By midafternoon, shares of bluebird had dropped 33.9%. Nasdaq halted trading because of volatility four times between 1:30 p.m. and 1:55 p.m.

The FDA’s label for bluebird’s drug included a warning that some patients who received the treatment had developed blood cancer. The label for the Vertex and Crispr drug included no such warning.

In a related financial setback, bluebird said Friday that the FDA hadn’t awarded the company a priority review voucher along with the approval of its gene therapy. Those vouchers entitle a company to speedier regulatory review of a drug, and are awarded by the agency along with certain approvals. Bluebird had already agreed to sell any priority review voucher it received along with the gene therapy approval to Novartis for $103 million; that sale won’t happen now.

The Vertex and Crispr gene therapy, which will be marketed under the name Casgevy, is also the first FDA-approved drug that uses a cutting-edge genome editing technology called Crispr/Cas9. That technology, described as “genetic scissors,” won a Nobel Prize in Chemistry in 2020 but had been out of reach for the patients it could benefit.

U.K. regulators approved Casgevy in mid-November. The approval of the bluebird bio gene therapy, Lyfgenia, came as a surprise; an FDA decision on the treatment wasn’t expected until Dec. 20.



Thursday, December 7, 2023

Unusual Options Activity Thur 12/7/23

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:

  • HPQ Dec 29.5 calls (volume: 16.3K, open int: 40, implied vol: ~35%, prev day implied vol: 22%). Co is expected to report earnings late February,
  • DDOG Dec 117 calls (volume: 4120, open int: 230, implied vol: ~49%, prev day implied vol: 44%). Stifel upgraded to Buy. Co is expected to report earnings mid-February,
  • INGN Jan24 7.5 calls (volume: 2670, open int: 0, implied vol: ~35%, prev day implied vol: 31%). Co is expected to report earnings late February.

Bearish Put Activity:

  • COIN Dec 130 puts (volume: 3140, open int: 9760, implied vol: ~100%, prev day implied vol: 88%). Co is expected to report earnings late February.
  • TSM Dec 96 puts (volume: 2220, open int: 4030, implied vol: ~42%, prev day implied vol: 31%). 1750 contracts traded in a single transaction. Co is expected to report earnings mid-January.

Sentiment: The CBOE Put/Call ratio is currently: 0.89, VIX: (13.01, +0.04, +0.3%).
December 15 is options expiration -- the last day to trade December equity options.

===Cerevel Therapeutics (CERE) to be acquired by AbbVie (ABBV) for $45.00/share in cash


AbbVie confirms it will acquire Cerevel Therapeutics (CERE) for $45.00/share in cash; total equity value of approximately $8.7 bln; to be accretive to EPS in 2030
  • Under the terms of the transaction, AbbVie will acquire all outstanding shares of Cerevel (CERE 36.93 +1.34) for $45.00 per share in cash. The transaction values Cerevel at a total equity value of approximately $8.7 billion. The boards of directors of both companies have approved the transaction. This transaction is expected to close in the middle of 2024, subject to Cerevel shareholder approval, regulatory approvals, and other customary closing conditions.
  • Proposed acquisition adds robust pipeline of assets focused on best-in-class potential for psychiatric and neurological disorders where significant unmet needs remain.
  • Cerevel's clinical-stage pipeline complements AbbVie's current on-market portfolio and emerging neuroscience pipeline.
  • Emraclidine has the potential to transform the standard of care in schizophrenia and other psychiatric conditions.
  • The proposed transaction is expected to be accretive to ABBV's adjusted diluted earnings per share beginning in 2030

Monday, December 4, 2023

==Science Applications (SAIC) reported earnings on Mon 4 Dec 23 (b/o)


Science Applications beats by $0.58, beats on revs; raises FY24 EPS above consensus, revs above consensus
  • Reports Q3 (Oct) earnings of $2.27 per share, $0.58 better than the FactSet Consensus of $1.69; revenues fell 0.7% year/year to $1.9 bln vs the $1.79 bln FactSet Consensus.
  • Co issues upside guidance for FY24, sees EPS of $7.70-7.90 vs. $7.42 FactSet Consensus and above prior guidance of $7.20-7.40; sees FY24 revs of $7.33-7.35 bln vs. $7.24 bln FactSet Consensus and above prior guidance of $7.20-7.25 bln.

Friday, December 1, 2023

Insider Trading Fri 12/1/23

Notable purchases -- JANA Partners adds to MRCY; notable sales -- President/COO active in FRT


  • AGL Director bought 22,300 shares at $11.12 - $11.30 worth ~$250K.
  • BMY Chief Executive Officer bought 3,071 shares at $48.86 worth ~$150K.
  • GDRX Interim Chief Executive Officer bought 30,505 shares at $5.82 - $6.00 worth ~$180K.
  • MRCY 10% owner JANA Partners bought 245,964 shares at $33.02 - $34.22 worth more than $8.2 mln.
  • OUST Director bought 10,000 shares at $5.22 - $5.25 worth ~$52K.
  • RMAX 10% owner bought 36,687 shares at $8.78 - $9.00 worth ~$325K.
  • RNGR Chief Executive Officer and Chief Financial Officer bought a total of 25,000 shares at $9.68 - $9.99 worth ~$247K.
  • STAA 10% owner Broadwood Partners bought 434,991 shares at $30.84 - $32.11 worth approx. $13.7 mln.
  • TTSH 10% owner bought 96,317 shares at $6.48 - $6.61 worth ~$632K.


  • CTGO Director sold 30,000 shares at $22.81 - $23.06 worth more than $687K.
  • EWBC Vice Chairman sold 12,000 shares at a weighted average price of $63.294 worth ~$759K.
  • FRT President and COO sold 4,870 shares at $94.86 worth ~$462K.