The Daily Biotech Pulse: Precision Biosciences Regains Rights To CAR T Candidates, CFO Changes, 2 IPOs

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs April 15)

Ardelyx, Inc. ARDX
BioNTech SE BNTX
Globus Medical, Inc. GMED
GW Pharmaceuticals plc GWPH
Medpace Holdings, Inc. MEDP
Medtronic plc MDT
Merit Medical Systems, Inc. MMSI
Natus Medical Incorporated NTUS
PPD, Inc. PPD ( moved on confirmation of deal to be bought by Thermo Fisher Scientific Inc. TMO)
Supernus Pharmaceuticals, Inc. SUPN
Surmodics, Inc. SRDX
Syneos Health, Inc. SYNH

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 15)

4D Molecular Therapeutics, Inc. FDMT
Aprea Therapeutics, Inc. APRE
Bellerophon Therapeutics, Inc. BLPH
Checkmate Pharmaceuticals, Inc. CMPI
Enveric Biosciences, Inc. ENVB
Evofem Biosciences, Inc. EVFM
Hoth Therapeutics, Inc. HOTH
Idera Pharmaceuticals, Inc. IDRA
Instil Bio, Inc. TIL
Karyopharm Therapeutics Inc. (KPTI)
Kronos Bio, Inc. KRON
Metacrine, Inc. MTCR
Millendo Therapeutics, Inc. MLND
NeuroBo Pharmaceuticals, Inc. (NRBO)
PainReform Ltd. PRFX
Qualigen Therapeutics, Inc. QLGN
Reviva Pharmaceuticals Holdings, Inc. RVPH
Titan Pharmaceuticals, Inc. TTNP
Universe Pharmaceuticals INC UPC

Stocks In Focus

Precision Biosciences to Reacquire Rights to CAR-T Therapies From Servier

Precision BioSciences, Inc. DTIL said it has entered into an agreement to reacquire all global development and commercialization rights for all CAR T partnered programs covered under its licensing agreement with Servier. This includes Precision's two clinical stage CD19-targeting allogeneic CAR T candidates, PBCAR0191 and PBCAR19B stealth cell, as well as four additional product targets.

Under the purchase agreement, Servier will receive $1.25 million in cash, while it is not required to pay Precision earned, but as-yet unpaid, milestones, totaling $18.75 million. Servier is also eligible to receive milestones and low- to mid-single-digit royalties subject to product development achievement.

Veracyte CFO To Retire, Pre-announces Above-consensus Q1 Revenues

Veracyte, Inc. VCYT said Keith Kennedy, chief financial officer and chief operating officer, will retire from the company, effective May 15, following the release of its full quarterly financial results and the filing of its Form 10-Q for the first quarter of 2021.

Jane Alley, vice president and corporate controller, will become acting CFO until a replacement is named.

For the first quarter, the company expects revenues of $36 million to $37 million, including about $3.5 million to $3.8 million for urologic cancers. This represented a 17.3% year-over-year increase at the midpoint of the range. Analysts, on average, estimate revenues of $32.06 million for the quarter.

Lexaria Announces CFO Transition, Issuance of Warrants to Third-party Consultants

Lexaria Bioscience Corp. LEXX announced the departure of its CFO Allan Spissinger and the appointment of Gregory Downey to the position.

The company also said effective on April 16, it will be issuing share purchase for the issuance of up to an aggregate 300,000 common shares to three unrelated third-party consultants. The warrants will be exercisable for a period of three years ending on April 16, 2024 at an exercise price of US$9.00 per share.

Qorvo Announces Emergency Use Authorization For COVID-19 Antigen Test In The U.S

Qorvo QRVO said the Food and Drug Administration has granted emergency use authorization for the Qorvo Omni SARS-CoV-2 Antigen Test. The test is authorized for the qualitative detection of nucleocapsid viral antigens from SARS-CoV-2 in nasal swab specimens from individuals who are suspected of COVID-19.

Lilly Requests For Revocation of EUA For Antibody Treatment For COVID-19 In Favor of Use of Combo Antibody Therapy

Eli Lilly and Company LLY said it has requested the FDA to evoke the emergency use authorization for bamlanivimab, 700 mg, alone due to the evolving variant landscape in the U.S. and the full availability of bamlanivimab and etesevimab together. This company clarified that the request is not due to any new safety concern.

"This final step in Lilly's transition to only supply bamlanivimab and etesevimab for administration together in the U.S. for the treatment of COVID-19 – as planned with the FDA – follows the modification of contracts with the U.S. government to ensure adequate supply of etesevimab to be used together with bamlanivimab," the company said.

The company said it's not requesting the withdrawal of emergency authorization for bamlanivimab alone in any other jurisdiction at this time. The company is manufacturing the antibody combo therapy along with Amgen Inc. AMGN.

Roche to Present Positive Long-term Data For Ocrevus In Relapsing and Primary Progressive Multiple Sclerosis

Roche Holding AG RHHBY announced new analyses of data for multiple sclerosis drug Ocrevus, which support its significant benefit on disease progression in early-stage relapsing-remitting multiple sclerosis and primary progressive multiple sclerosis, as well as demonstrating high persistence and strong adherence to twice-yearly dosing.

Ocrevus is an approved MS medication in the U.S. for patients starting a new treatment.

NantHealth Gains On Insider Buying

NantHealth, Inc. NH reacted to a Form 4 filing, which revealed CEO Patrick Soon-Shiang bought 1,689,189 shares in the company at $2.96 apiece.

The shares rose 3.45% to $2.70 in after-hours trading.

Offerings

Synlogic SYBX said it has commenced an underwritten public offering of its common stock. All shares of common stock to be sold in the offering will be offered by Synlogic.

The stock was down 2.85% to $3.07 in after-hours trading.

On The Radar

IPOs

Biomea Fusion, Inc., a preclinical-stage biopharma focused on the discovery, development and commercialization of irreversible small molecules to treat patients with genetically defined cancers, priced its upsized initial public offering of 9 million shares at a price of $17 per share, the upper bound of the estimated price range of $15-$17. All of the shares of common stock are being offered by Biomea.

The gross proceeds from the offering are expected to be $153 million. Biomea's common stock is expected to begin trading on the Nasdaq under the ticker symbol "BMEA."

Akoya Biosciences, Inc. AKYA, which delivers spatial biology solutions focused on transforming discovery and clinical research, priced its IPO of 6.58 million shares at a price of $20 per share, for gross proceeds of $131.6 million. The company had previously estimated a price range of $18-$20. The shares are expected to begin trading on the Nasdaq under the ticker symbol "AKYA."

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