The Daily Biotech Pulse: Bristol-Myers, Bluebird Bio Resubmit Multiple Myeloma Drug BLA, FSD To Close Medicinal Cannabis Business, Hologic's Blowout Quarter

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs July 29)

• Abbott Laboratories ABT
• ABIOMED, Inc. ABMD
• Adamis Pharmaceuticals Corp ADMP
• Annexon Inc ANNX (went public Friday)
• Bio-Rad Laboratories, Inc. Class B (NYSE: BIO-B)
• Hologic, Inc. HOLX
• Intuitive Surgical, Inc. ISRG
• ITAMAR MED LTD/S ADR ITMR
• Merit Medical Systems, Inc. MMSI
• NeoGenomics, Inc. NEO
• Novavax, Inc. NVAX
• OncoSec Medical Inc ONCS
• Paratek Pharmaceuticals Inc PRTK (moved on rumors of a BARDA loan)
• Penumbra Inc PEN
• Qiagen NV QGEN
• Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 29)

• Forma Therapeutics Holdings Inc (NASDAQ: FMTX
• Genfit SA GNFT
• Gritstone Oncology Inc GRTS
• Nkarta Inc NKTX
• ORIC Pharmaceuticals Inc ORIC
• RA Medical Systems Inc RMED
• Sonnet BioTherapeutics Holdings, Inc. SONN
• Tricida Inc TCDA
• Verrica Pharmaceuticals Inc VRCA

Stocks In Focus

Spring Bank To Merge With Privately Held F-Star Therapeutics

Spring Bank Pharmaceuticals Inc SBPH said it will merge with privately held F-star Therapeutics, Limited, an oncology-focused biopharma. The merger is to effected as a share exchange transaction.

The combined company, operating under the name F-star Therapeutics, will advance F-Star's immuno-oncology pipeline of multiple tetravalent bispecific antibody programs, as well as Spring Bank's STING agonist, SB 11285, which is in a Phase 1/2 clinical trial.

Spring Bank shares were up 31.73% at $2.74 premarket Thursday.

Bristol-Myers, Bluebird Resubmit Multiple Myeloma Immunotherapy Regulatory Application

Bristol-Myers Squibb Co BMY and bluebird bio Inc BLUE said they have resubmitted the NDA for idecabtagene vicleucel, their investigational B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma.

The submission provides additional details on the Chemistry, Manufacturing and Controls module to address the outstanding regulatory requests from the FDA in May 2020 following the original BLA submission from March 2020.

In premarket trading, Bristol-Myers Squibb shares were down 0.76% at $58.70 and Bluebird bio shares were trading 0.58% higher at $62.70.

BioNTech Announces Publication Of Positive Phase 1 Data For Cancer Vaccine

BioNTech SE – ADR BNTX announced the publication of interim Phase 1 data for its FixVac cancer vaccine program BNT111 in the journal Nature. The company noted that the study evaluated safety and tolerability of vaccinated patients with stage IIIB-C and stage IV melanoma.

"The interim data shows that BNT111 alone and in combination with PD-1 checkpoint blockade, while being well tolerated, mediates durable objective responses in melanoma patients that had progressed after prior checkpoint blockade," the company said.

Vaccine-induced antigen-specific memory T cells persisted for more than one year under continuous monthly vaccination, according to BioNTech.

See also: The Week Ahead In Biotech: Spotlight On GW Pharma, Ultragenyx FDA Decisions, Pfizer Earnings

Quest Diagnostics Announces EUA For Technique To Increase COVID-19 Molecular Diagnostics Capacity

Quest Diagnostics Inc DGX said the FDA granted emergency use authorization for a new laboratory technique that speeds the process of extracting viral RNA from specimens and will enable the company to expand its daily capacity of COVID-19 molecular diagnostic tests on behalf of patients in the United States.

The stock gained 1.81% to $128.41 in after-hours trading.

FSD To Close Medicinal Cannabis Operations In Bid To Focus On Pharma Operations

FSD Pharma Inc HUGE said it has notified Health Canada of its decision to forfeit the licenses of its wholly owned subsidiary, FV Pharma, and suspend all activities by FV Pharma within 30 days of the notification date.

FSD Pharma said it has started the process of liquidating all FV Pharma assets, including the sale of the company's cannabis production facility in Cobourg, Ontario.

Instead, the company said it will advance pharmaceutical R&D efforts on its lead compound FSD201, while also continuing to explore the acquisition of other compelling compounds to expand its drug development pipeline.

FSD said it is working on submitting an IND to the FDA for the use of FSD201 to treat hospitalized COVID-19 patients. The company also anticipates starting a Phase 2 trial before the end of 2020.

The stock was soaring 140.91% to $9.01 premarket Thursday.

Imara Lead Asset Gets Fast Track Designation, Rare Pediatric Drug Designation For Beta-Thalassemia

Imara Inc IMRA said the FDA granted Fast Track designation and Rare Pediatric Disease designation for its lead clinical asset, IMR-687, for the treatment of beta-thalassemia.

Earnings

Hologic reported third-quarter revenue of $822.9 million, down 3.5% due to the Cynosure divestiture. Organic revenues were up 7.7%. The company reported non-GAAP EPS of 75 cents, well ahead of the 38-cent-per-share consensus estimate.

Citing strong demand for its COVID-19 tests and the ongoing recovery of the other divisions, the company issued above-consensus guidance for the fourth quarter.

The stock was up 9.34% premarket at $69.98.

Alimera Sciences Inc ‘s ALIM second-quarter revenue fell 8% year-over-year to $10 million and the loss per share narrowed from $1.06 to 51 cents. Analysts, on average, estimated a loss of $1.61 per share.

The stock jumped 32.12% to $8 in after-hours trading.

Genocea Announces Positive Initial Phase 1/2 Data For Neoantigen Vaccine Candidate In Advanced Solid Tumors

Genocea Biosciences Inc GNCA said initial clinical data on the first five patients from Part B of a Phase 1/2 study that's exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors showed that three achieved independent RECIST responses starting from the first GEN-009 dose.

Overall, two of the first five patients achieved complete responses and three experienced partial responses, the company said.

The stock was gaining 6.84% to $4.63 premarket Thursday.

Offerings

Spectrum Pharmaceuticals, Inc. SPPI, which saw its shares skyrocket Tuesday following a positive readout, came under pressure after it said it intends to offer shares of its common stock in an underwritten registered public offering. The company priced its 21.67-million-share common stock offering at $3 per share for raising gross proceeds of about $65 million.

All of the shares in the offering are to be sold by the company.

The stock was down 17.53% premarket to $3.20. 

On The Radar

Earnings

• Lexicon Pharmaceuticals, Inc. LXRX (before the market open)
• Repligen Corporation RGEN (before the market open)
• Novocure Ltd NVCR (before the market open)
• Blueprint Medicines Corp BPMC (before the market open)
• Iradimed Corp IRMD (before the market open)
• Alexion Pharmaceuticals, Inc. ALXN (before the market open)
• Agios Pharmaceuticals Inc AGIO (before the market open)
• Eli Lilly And Co LLY (before the market open)
• Elanco Animal Health Inc ELAN (before the market open)
• Evelo Biosciences Inc EVLO (before the market open)
• BioTelemetry Inc BEAT (after the close)
• MacroGenics Inc MGNX (after the close)
• Vertex Pharmaceuticals Incorporated VRTX (after the close)
• Emergent Biosolutions Inc EBS (after the close)
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO (after the close)
• Anika Therapeutics Inc ANIK (after the close)
• Gilead Sciences, Inc. GILD (after the close)
• Natus Medical Inc NTUS (after the close)
• Retrophin Inc RTRX (after the close)
• Veracyte Inc VCYT (after the close)
• Ultragenyx Pharmaceutical Inc RARE (after the close)
• Globus Medical Inc GMED (after the close)
• Quidel Corporation QDEL (after the close)
• EXACT Sciences Corporation EXAS (after the close)
• Aimmune Therapeutics Inc AIMT (after the close)
• Corvus Pharmaceuticals Inc CRVS (after the close)
• MacroGenics Inc MGNX (after the close)

Related Link: Pfizer Analyst Says COVID-19-Driven Rally Not Backed By Vaccine Economics