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The Daily Biotech Pulse: Novavax Advances Vaccine, Marinus Gets Nod For Late-Stage Study, 3 IPOs

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The Daily Biotech Pulse: Novavax Advances Vaccine, Marinus Gets Nod For Late-Stage Study, 3 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 Sept. 24)

  • Beigene Ltd (NASDAQ: BGNE))
  • Forte Biosciences Inc (NASDAQ: FBRX)
  • Pacific Biosciences of California Inc (NASDAQ: PACB)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 24)

  • ADiTx Therapeutics Inc (NASDAQ: ADTX)
  • AEterna Zentaris Inc. (NASDAQ: AEZS)
  • Akebia Therapeutics Inc (NASDAQ: AKBA)
  • Alector Inc (NASDAQ: ALEC)
  • AnPac Bio-Medical Science Co Ltd – ADR (NASDAQ: ANPC)
  • Amarin Corporation plc (NASDAQ: AMRN)
  • Athira Pharma Inc (NASDAQ: ATHA)
  • BELLUS Health Inc (NASDAQ: BLU)
  • Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP)
  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)
  • DBV Technologies ADR Representing 0.5 Ord Shs (NASDAQ: DBVT)
  • Evofem Biosciences Inc (NASDAQ: EVFM)
  • Fusion Pharmaceuticals Inc (NASDAQ: FUSN)
  • Genetron Holdings Ltd – ADR (NASDAQ: GTH)
  • Genfit SA (NASDAQ: GNFT)
  • Gritstone Oncology Inc (NASDAQ: GRTS)
  • Happiness Biotech Group Ltd (NASDAQ: HAPP)
  • Histogen Inc (NASDAQ: HSTO)
  • Hoth Therapeutics Inc (NASDAQ: HOTH)
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)
  • Natus Medical Inc (NASDAQ: NTUS)
  • Neos Therapeutics Inc (NASDAQ: NEOS)
  • Neurobo Pharmaceuticals Inc (NASDAQ: NRBO)
  • NextCure Inc (NASDAQ: NXTC)
  • Odonate Therapeutics Inc (NASDAQ: ODT)
  • Oncternal Therapeutics Inc (NASDAQ: ONCT)
  • PainReform Ltd (NASDAQ: PRFX)
  • Pandion Therapeutics Inc (NASDAQ: PAND)
  • Pliant Therapeutics Inc (NASDAQ: PLRX)
  • Psychemedics Corp. (NASDAQ: PMD)
  • RA Medical Systems Inc (NYSE: RMED)
  • Renalytix AI PLC (NASDAQ: RNLX)
  • Rockwell Medical Inc (NASDAQ: RMTI)
  • Satsuma Pharmaceuticals Inc (NASDAQ: STSA)
  • SCYNEXIS Inc (NASDAQ: SCYX)
  • Solid Biosciences Inc (NASDAQ: SLDB)
  • Sonnet BioTherapeutics Holdings, Inc. (NASDAQ: SONN)
  • Teligent Inc (NEW JERSEY) (NASDAQ: TLGT)
  • Theravance Biopharma Inc (NASDAQ: TBPH)
  • Tricida Inc (NASDAQ: TCDA)
  • Vaccinex Inc (NASDAQ: VCNX)
  • Viveve Medical Inc (NASDAQ: VIVE)
  • Taro Pharmaceutical Industries Ltd. (NYSE: TARO)

Stocks In Focus

Novavax Commences Phase 3 Study of Coronavirus Vaccine Candidate

Novavax, Inc. (NASDAQ: NVAX) said it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, its COVID-19 vaccine candidate.

The trial is being conducted in the U.K. in partnership with the UK Government's Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals, ages 18-84 years, with and without relevant comorbidities, over the next four to six weeks, Novavax said.

Separately, Endo International PLC (NASDAQ: ENDP) announced a non-exclusive agreement with Novavax to provide fill-finish manufacturing services at its plant in Rochester, Michigan for NVX-CoV2373.

In pre-market trading Friday, Novavax shares were up 7.48% to $110.10, and Endo was gaining 9.27% to $3.30.

Altimmune Rallies On Institutional Buying

Altimmune Inc (NASDAQ: ALT) shares moved after a filing by the company revealed D.E. Shaw and D.E. Shaw & Co. each beneficially own 1,634,730 shares, or 5% stake in the company.

The stock rallied 8.89% to $13.10 in after-hours trading.

Clover Biopharma Announces Positive Preliminary Phase 1 Results From Coronavirus Vaccine Program

Clover Biopharma, which is developing a protein-based COVID-19 S-Trimer vaccine candidate in combination with adjuvants from GlaxoSmithKline plc (NYSE: GSK) or Dynavax Technologies Corporation (NASDAQ: DVAX) said the investigational vaccine induced a strong immune response and protection against SARS-CoV-2 in animal models.

Clover also announced preliminary results from a Phase 1 study showing that the vaccine is likely to be safe and well-tolerated, with high levels of neutralizing antibodies.

Based on these preliminary results, an additional 200 participants will be enrolled in a Phase 1 dose-expansion study at the selected S-Trimer dose-level and adjuvanted with either GSK's pandemic adjuvant or Dynavax's advanced adjuvant CpG 1018 plus alum, the company said.

Clover also said it plans to initiate a Phase 2/3 efficacy study before the end of 2020.

Genfit Announces First Patient Visit In Pivotal Phase 3 Study of Elafibranor In Primary Biliary Cholangitis

Genfit announced the first patient first visit for ELATIVE, its global, pivotal, Phase 3 study evaluating the efficacy and safety of elafibranor in primary biliary cholangitis, or PBC.

"This is a significant milestone and it means that we are now a step closer to hopefully bringing patients and caregivers a promising option to treat this debilitating disease and its symptoms. We see an important potential for elafibranor in PBC and will provide further information at the upcoming Corporate Update on September 30" said Pascal Prigent, CEO at GENFIT.

In after-hours trading, the stock jumped 13.08% to $4.15.

Radius Health, Partner Say Enrollment Into Phase 3 Study of Breast Cancer Drug Completed

Radius Health Inc (NASDAQ: RDUS) and partner Menarini Group said the target enrollment milestone has been reached in the Phase 3 EMERALD clinical trial of elacestrant that is being studied in postmenopausal women and men with ER+/HER2- advanced or metastatic breast cancer.

The companies expect to conduct primary analysis of data from the study in the second half of 2021. An independent data monitoring committee that reviewed results of futility analysis conducted after the completion of 70% of targeted enrollment recommended that the study proceed without modification, the companies said.

Marinus Cleared to Initiate Registrational Phase 3 Study of Ganaxolone In Refractory Status Epilepticus

Marinus Pharmaceuticals Inc (NASDAQ: MRNS) said it has satisfied the FDA's protocol-specific questions for the registrational Phase 3 trial of intravenous ganaxolone in refractory status epilepticus, allowing enrollment to begin in this clinical trial. The company expects the first patient to be enrolled in October and release topline data in the first half of 2022.

Marinus recently reported positive Phase 3 results for ganaxolone in CDKL5 deficiency disorder

In pre-market trading, the stock was adding 5.61% to $11.30.

On The Radar

IPOs

Prelude Therapeutics, a clinical-stage precision oncology company, priced its initial public offering, or IPO, of 8.325 million shares at $19 per share, the upper end of the estimated price range of $17-$19. Gross proceeds from the offering are expected at $158.2 million. The shares will begin trading on the Nasdaq under the ticker symbol PRLD.

Greenwich LifeSciences Inc., a clinical-stage biopharma focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, priced its IPO of 1.261 million shares at $5.75 apiece, for raising gross proceeds of $7.25 million. The shares will begin trading on the Nasdaq under the symbol GLSI.

MV Pharmaceuticals, Inc., a precision oncology company, priced its IPO of 11.765 million shares at $18 per share. The shares are expected to begin trading on the Nasdaq under the ticker symbol PMVP.

 

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