The Daily Biotech Pulse: Novavax Vaccine Data, Axovant Flags Delay In Parkinson's Study, 2 Biotechs Make Wall Street Debuts

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 Oct. 29)

• BioLife Solutions Inc BLFS
• Blueprint Medicines Corp BPMC (reacted to third-quarter results)
• Idera Pharmaceuticals Inc IDRA
• Keros Therapeutics Inc KROS
• Merit Medical Systems, Inc. MMSI (reacted to third-quarter results)
• Mirati Therapeutics Inc MRTX
• Penumbra Inc PEN (reacted to third-quarter results)
• Praxis Precision Medicines Inc PRAX
• Spruce Biosciences Inc SPRB
• United Therapeutics Corporation UTHR
• X T L Biopharmaceuticals Ltd XTLB

Down In The Dumps

• (Biotech Stocks Hitting 52-week Lows Oct. 29)
• Akebia Therapeutics Inc AKBA
• Aziyo Biologics Inc AZYO
• Baudax Bio Inc BXRX
• BioCardia Inc BCDA
• Biodesix Inc BDSX (listed on Nasdaq Wednesday)
• Biogen Inc BIIB
• Catabasis Pharmaceuticals Inc CATB
• DBV Technologies ADR Representing 0.5 Ord Shs DBVT
• Entasis Therapeutics Holdings Inc ETTX
• Evolus Inc EOLS
• Galecto Inc GLTO (listed on the Nasdaq Thursday)
• Gilead Sciences, Inc. GILD (reacted to third-quarter results)
• Immunome Inc IMNM
• Invivo Therapeutics Holdings Corp NVIV
• Lexicon Pharmaceuticals, Inc. LXRX (reacted to third-quarter results)
• Neovasc Inc NVCN
• Neurobo Pharmaceuticals Inc NRBO
• Oncternal Therapeutics Inc ONCT
• Opiant Pharmaceuticals Inc OPNT (announced a partnership with Aptar for nasal nalmefene opioid overdose treatment)
• Opthea Limited OPT
• Orphazyme A S ADR ORPH
• Predictive Oncology Inc POAI
• Psychemedics Corp. PMD
• Recro Pharma Inc REPH
• Rockwell Medical Inc RMTI
• Royalty Pharma plc RPRX
• Sunesis Pharmaceuticals, Inc. SNSS
• Tricida Inc TCDA (communicated a potential delay in approval of its metabolic acidosis investigational drug)

Stocks In Focus

Equillium Gets FDA's OK To Initiate Late-Stage COVID-19 Study

Equillium Inc EQ sad it has received a study-may-proceed letter from the FDA to begin a Phase 3 clinical trial named EQUINOX that evaluates itolizumab in hospitalized COVID-19 patients suffering from acute respiratory distress syndrome.

The company said it plans to start enrolling patients during the fourth quarter, with initial clinical data expected midyear in 2021. The FDA has indicated that the trial — if it meets its primary and key secondary endpoints — may be sufficient to support regulatory filing of a BLA.

The stock was up 28.67% to $7.72 premarket Friday.

Axovant Sinks On Potential Delay In Parkinson's Gene Therapy Program

Axovant Gene Therapies Ltd AXGT announced updates to be presented at its virtual Parkinson's disease R&D day, stating individual patient-level data from cohort 2 of the Phase 2 SUNRISE-PD study that is evaluating its AXO-Lenti-PD gene therapy for the treatment of Parkinson's disease showed favorable safety and tolerability profile, with no serious adverse events.

The company also said it is unlikely that its planned sham-controlled trial of AXO-Lenti-PD will begin to enroll patients by the end of calendar year 2021.

The potential delay is due to its manufacturing partner Oxford Biomedica informing delays in CMC data and third-party fill/finish issues. Therefore, the development of a suspension-based manufacturing process for AXO-Lenti-PD will take longer than expected, Axovant said.

The stock was down 31.51% premarket at $2.50. 

Bausch Health Lands Orphan Drug Designation In Sickle Cell Disease

Bausch Health Companies Inc BHC said the FDA has granted orphan drug designation to rifaximin for the treatment of sickle cell disease.

The stock was edging down 0.3% to $16.80 in premarket trading Friday.

Related Link: The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs

Biogen Announces Acceptance Of European Regulatory Application For Aducanumab

Biogen and partner Eisai Co., Ltd ESALY said the European Medicines Agency has confirmed it has accepted for review, following a standard timetable, the marketing authorization application for aducanumab, an investigational treatment for Alzheimer's disease.

Bellicum's Drug Flunks Pancreatic Cancer Study

Bellicum Pharmaceuticals Inc BLCM announced interim data from its BPX-601 dose-escalation clinical trial in patients with relapsed/refractory metastatic pancreatic cancer, showing the first four patients treated with BPX-601 followed by repeat rimiducid dosing showed evidence of rimiducid-mediated CAR-T cell activation.

Clinically meaningful efficacy as measured by RECIST criteria was not observed, Bellicum said.

After an extensive review of its organization and programs, the company said it has enacted a restructuring plan, including a reduction in staff, to focus its efforts on its clinical GoCAR-T product candidates.

In premarket trading Friday, the stock was plunging 33.05% to $3.95.

Earnings

Strongbridge Biopharma plc SBBP reported third-quarter revenue of $8.07 million compared to $5.68 million in the year-ago quarter. The loss per share narrowed from 31 cents to 18 cents.

The stock was up 1.59% premarket at $1.92. 

Opko Health Inc.'s OPK third-quarter revenue jumped from $228.8 million in 2019 to $428.1 million in 2020, boosted by increased COVID-19 testing volume.

The company reversed from a loss of 11 cents per share to a profit of 4 cents per share.

While the revenues were ahead of expectations, the bottom-line performance trailed expectations.

The stock was down 7.86% premarket at $3.87.

ResMed Inc. RMD said its fiscal-year 2021 first-quarter revenues climbed 10% year-over-year to $751.9 million. Non-GAAP EPS climbed from 93 cents to $1.27. The results exceeded expectations.

In premarket trading Friday, the stock was trading 10.3% higher at $198. 

AxoGen, Inc's Common Stock AXGN third-quarter revenues climbed 17% year-over-year to $28.6 million.

On an adjusted non-GAAP basis, the company reversed from a loss of 7 cents per share to a profit of 4 cents per share.

The stock was adding 2.12% to $13 premarket Friday.

On The Radar

Clinical Readouts

Novavax, Inc. NVAX will present data from its ongoing Phase 1/2 COVID-19 clinical trial, including new Phase 2 reactogenicity data, during the CDC's Advisory Committee on Immunization Practices meeting.

Earnings

• AbbVie Inc ABBV (before the market open)
• Ligand Pharmaceuticals Inc. LGND (before the market open)

IPOs

Boston, Massachusetts-based Atea Pharma, a clinical-stage biopharma focused on developing antiviral therapeutics, priced its upsized initial public offering of 12.5 million shares at $24 each to raise gross proceeds of $300 million.

The company had earlier estimated a price range of $22-$24. Atea's common stock will begin trading on the Nasdaq under the ticker symbol "AVIR."

SQZ Biotechnologies Co., a Watertown, Massachusetts-based biopharma, priced its IPO of 4.412 million shares at $16 per share, at the lower end of the estimated price range of $16-$18. The shares will begin trading on the Nasdaq under the ticker symbol "SQZ."

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates