The Daily Biotech Pulse: Dynavax Poaches GSK Vaccine Exec, KalVista Jumps On Data Readout, Corcept Issues Negative Preannouncement

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 Feb. 9)

• Abbott Laboratories (NYSE: ABT)

• AEterna Zentaris Inc. (NASDAQ: AEZS)

• Alkermes Plc (NASDAQ: ALKS)

• AngioDynamics, Inc. (NASDAQ: ANGO)

• Anixa Biosciences Inc (NASDAQ: ANIX)

• Antares Pharma Inc (NASDAQ: ATRS)

• Applied Molecular Transport Inc. (NASDAQ: AMTI)

• Arcus Biosciences Inc (NYSE: RCUS)

• AtriCure Inc. (NASDAQ: ATRC)

• aTyr Pharma Inc (NASDAQ: LIFE)

• Beam Therapeutics Inc (NASDAQ: BEAM)

• Bioatla Inc (NASDAQ: BCAB)

• BioLineRx ADR Representing 15 Ord Shs (NASDAQ: BLRX)

• Bolt Biotherapeutics Inc (NASDAQ: BOLT) (went public Friday)

• BridgeBio Pharma Inc (NASDAQ: BBIO)

• C4 Therapeutics Inc (NASDAQ: CCCC)

• Castle Biosciences Inc (NASDAQ: CSTL)

• Celldex Therapeutics, Inc. (NASDAQ: CLDX)

• ChemoCentryx Inc (NASDAQ: CCXI)

• Chimerix Inc (NASDAQ: CMRX)

• Collplant Biotechnologies Ltd – ADR (NASDAQ: CLGN) – announced an exclusive development and commercialization agreement for dermal and soft tissue filler products with AbbVie Inc’s (NYSE: ABBV) Allergan

• Corcept Therapeutics Incorporated (NASDAQ: CORT)

• DarioHealth Corp (NASDAQ: DRIO)

• DermTech Inc (NASDAQ: DMTK)

• Dicerna Pharmaceuticals Inc (NASDAQ: DRNA)

• Edap Tms SA (NASDAQ: EDAP)

• Enlivex Therapeutics Ltd (NASDAQ: ENLV)

• Eton Pharmaceuticals Inc (NASDAQ: ETON) (announced sale of neurology portfolio)

• Evaxion Biotech A/S – ADR (NASDAQ: EVAX) (went public Friday)

• Evogene Ltd (NASDAQ: EVGN)

• FibroGen Inc (NASDAQ: FGEN)

• Frequency Therapeutics Inc (NASDAQ: FREQ)

• Fulgent Genetics Inc (NASDAQ: FLGT)

• G1 Therapeutics Inc (NASDAQ: GTHX)

• Genetron Holdings Ltd – ADR (NASDAQ: GTH)

• Genprex Inc (NASDAQ: GNPX) (announced formation of clinical advisory board to support its oncology and diabetes programs)

• Halozyme Therapeutics, Inc. (NASDAQ: HALO)

• Harvard Bioscience, Inc. (NASDAQ: HBIO)

• Horizon Therapeutics PLC (NASDAQ: HZNP)

• Ideaya Biosciences Inc (NASDAQ: IDYA) (announced regulatory nod to commence Phase 1 study of IDE397)

• Immunocore Holdings PLC – ADR (NASDAQ: IMCR) (went public Friday)

• ImmunoGen, Inc. (NASDAQ: IMGN)

• Inari Medical Inc (NASDAQ: NARI)

• Infinity Pharmaceuticals Inc. (NASDAQ: INFI)

• Inspire Medical Systems Inc (NYSE: INSP)

• Intra-Cellular Therapies Inc (NASDAQ: ITCI)

• iTeos Therapeutics Inc (NASDAQ: ITOS)

• Jounce Therapeutics Inc (NASDAQ: JNCE)

• Karuna Therapeutics Inc (NASDAQ: KRTX)

• Ligand Pharmaceuticals Inc. (NASDAQ: LGND)

• Lucira Health Inc (NASDAQ: LHDX) (went public Friday)

• Medpace Holdings Inc (NASDAQ: MEDP)

• MEI Pharma Inc (NASDAQ: MEIP)

• Meridian Bioscience, Inc. (NASDAQ: VIVO)

• MiMedx Group Inc (NASDAQ: MDXG)

• Misonix Inc (NASDAQ: MSON)

• Moderna Inc (NASDAQ: MRNA)

• Morphic Holding Inc (NASDAQ: MORF)

• Nantkwest Inc (NASDAQ: NK)

• Neubase Therapeutics Inc (NASDAQ: NBSE)

• Novan Inc (NASDAQ: NOVN)

• Novavax, Inc. (NASDAQ: NVAX) (capitalized on momentum ahead of key catalytic events)

• Ocugen Inc (NASDAQ: OCGN) (priced a registered direct offering at a 45.7% premium)

• Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (announced initiation of a confirmatory pharmacokinetic study for opioid overdose treatment OPNT003)

• Organogenesis Holdings Inc (NASDAQ: ORGO)

• Outlook Therapeutics Inc (NASDAQ: OTLK) (jumped on insider buying)

• Paratek Pharmaceuticals Inc (NASDAQ: PRTK) (announced expansion of commercial promotion of its antibiotic Nuzyra into community setting)

• Profound Medical Corp (NASDAQ: PROF)

• Prothena Corporation PLC (NASDAQ: PRTA)

• Pulse Biosciences Inc (NASDAQ: PLSE)

• Purple Biotech ADR (NASDAQ: PPBT)

• Qiagen NV (NYSE: QGEN)

• Radius Health Inc (NASDAQ: RDUS)

• Renalytix AI PLC (NASDAQ: RNLX)

• Rocket Pharmaceuticals Inc (NASDAQ: RCKT)

• Salarius Pharmaceuticals Inc (NASDAQ: SLRX)

• Seelos Therapeutics Inc (NASDAQ: SEEL)

• Sesen Bio Inc (NASDAQ: SESN)

• SI-Bone Inc (NASDAQ: SIBN)

• Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN)

• Summit Therapeutics Inc (NASDAQ: SMMT)

• Sutro Biopharma Inc (NASDAQ: STRO)

• Synlogic Inc (NASDAQ: SYBX)

• T2 Biosystems Inc (NASDAQ: TTOO)

• Terns Pharmaceuticals Inc (NASDAQ: TERN) (went public Friday)

• Translate Bio Inc (NASDAQ: TBIO)

• Trinity Biotech plc (NASDAQ: TRIB)

• Turning Point Therapeutics Inc (NASDAQ: TPTX)

• Vanda Pharmaceuticals Inc. (NASDAQ: VNDA)

• Veracyte Inc (NASDAQ: VCYT)

• Vericel Corp (NASDAQ: VCEL)

• Veru Inc (NASDAQ: VERU) (announced positive results for a Phase 2 study of VERU-111 in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome)

• Xencor Inc (NASDAQ: XNCR)

• Xeris Pharmaceuticals Inc (NASDAQ: XERS)

• ZIOPHARM Oncology Inc. (NASDAQ: ZIOP)

Down In The Dumps

Story continues

(Biotech Stocks Hitting 52-week Lows Feb. 9)

Stocks In Focus Dynavax Appoints GSK Veteran Dong Yu To Lead Vaccine Program

Dynavax Technologies Corporation (NASDAQ: DVAX) announced the appointment of Dong Yu as senior vice president of vaccine research and a member of the executive team.

Yu, a former GlaxoSmithKline plc (NYSE: GSK) executive, will be responsible for Dynavax’s vaccine programs and technology platforms, building and maintaining a pipeline for long-term company growth. Yu has years of experience at GlaxoSmithKline’s vaccine unit.

The move comes just after Clover, which was working on a COVID-19 vaccine combined with adjuvants from both Dynavax and GlaxoSmithKline, decided to move ahead with only Dynavax’s adjuvant.

Dynavax shares were down 0.98% premarket at $11.07.

Navidea Gains After FDA Grants Type B Meeting to Discuss Rheumatoid Arthritis Study

Navidea Biopharmaceuticals Inc (NYSE: NAVB) said it has submitted its formal Type B meeting request to the FDA and that the FDA has granted the Type B meeting and requested submission of the Briefing Book.

The FDA will now review Navidea’s formal briefing documents containing results from the NAV3-31 Phase 2b study and the proposed Phase 3 design and protocol. The NAV3-31 study is evaluating the precision and sensitivity of Tilmanocept Uptake Value on Tc 99m planar imaging in rheumatoid arthritis patients.

Navidea said it expects formal feedback from the FDA within the next several months and a potential launch of the pivotal Phase 3 study in the second quarter of 2021.

The stock was climbing 7.83% to $3.03 in premarket trading Tuesday.

Related Link: The Week Ahead In Biotech (Feb. 7-13): Regeneron FDA Decision, Earnings, IPOs and Conference Presentations In The Spotlight

Ironwood CEO to Depart

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that Mark Mallon plans to step down as chief executive officer and a member of the board in order to pursue another leadership opportunity, effective March 12.

The company named Thomas McCourt, Ironwood’s president, as interim CEO effective upon Mallon’s departure. The company also said it plans to initiate a candidate search.

The stock was rallying by 12.76% to $12.02 premarket.

KalVista’s Hereditary Angioedema Drug Aces Midstage Study

KalVista Pharmaceuticals Inc (NASDAQ: KALV) announced positive topline data from a Phase 2 clinical trial demonstrating statistically and clinically significant efficacy of KVD900 as an oral on-demand treatment for hereditary angioedema attacks.

The shares were jumping 220.69% to $50.06 premarket Tuesday.

AzurRx To Work With PPD For Phase 2 COVID-19 Study

AzurRx BioPharma Inc (NASDAQ: AZRX) said it has entered into an agreement with contract research organization PPD Inc (NASDAQ: PPD) for its planned Phase 2 clinical trial evaluating a proprietary formulation of micronized niclosamide as a treatment for COVID-19-associated gastrointestinal infections.

View more earnings on IBB

In premarket trading Tuesday, AzurRx shares were rallying 28.4% to $2.17.

Collegium to Join S&P SmallCap 600 Index

Standard & Poor’s announced that Collegium Pharmaceutical Inc (NASDAQ: COLL) will be added to the S&P SmallCap 600 Index, effective Feb. 12.

The stock was up 11.9% to $26.52 in premarket trading Tuesday.

Atea Announces Publication Of Positive Preclinical Data For COVID-19 Treatment

Atea Pharmaceuticals Inc (NASDAQ: AVIR) announced the publication of new data highlighting the highly potent in vitro antiviral activity of AT-527 against SARS-CoV-2, the virus that causes COVID-19. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea’s purine nucleotide prodrug platform.

“These new data underscore AT-527’s potential to treat COVID-19 and to have an impact on global health,” said Jean-Pierre Sommadossi, CEO of Atea.

Earnings

Corcept Therapeutics announced preliminary fourth-quarter revenue of $85.7 million, lower than $87.9 million in the year-ago quarter, and GAAP EPS of 20 cents. Analysts, on average, estimate revenues of $90.63 million.

For the full year 2020, the company expects revenue of $353.9 million, below the consensus estimate of $358.48 million.

The company guided 2021 revenue to $375 million to $405 million, surrounding the consensus estimate of $403.17 million.

In premarket trading Tuesday, the stock was retreating 8.38% to $28.

Offerings

Geovax Labs Inc (NASDAQ: GOVX) said it has entered into an underwriting agreement with Maxim Group, under which the underwriter has agreed to purchase 1.44 million shares of common stock of the company, at a price to the public of $6.25 per share. The gross proceeds from the offering are expected to be approximately $9 million.

The stock was slipping 8.96% to $6.81 in premarket trading Tuesday.

Autolus Therapeutics PLC (NASDAQ: AUTL) said it has commenced an underwritten public offering of up to $100 million in American depository shares, with each ADS representing one ordinary share. All shares to be sold in the proposed offering will be offered by Autolus.

In premarket trading, the stock was down 1.16% at $8.53.

On The Radar Clinical Readouts

Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) is scheduled to present at the 17th Annual WORLDSymposium with updated Phase 1/2 data for ex-vivo autologous stem cell gene therapy for mucopolysaccharidosis type IIIA and Phase 1/2 data for ex vivo hematopoietic stem cell gene therapy for mucopolysaccharidosis type I.

Gamida Cell Ltd (NASDAQ: GMDA) will present at the Transplantation and Cellular Therapy meeting with results of the Phase 1 study of omidubicel versus standard myeloblative umbilical cord blood transplantation in patients with hematologic malignancies undergoing allogeneic bone marrow transplant.

Magenta Therapeutics Inc (NASDAQ: MGTA) is due to present at the TCT meeting Phase 1 data for MGTA-145, in combination with plerixafor.

Earnings:

• Incyte Corporation (NASDAQ: INCY) (before the market open)

• Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) (before the market open)

• SurModics, Inc. (NASDAQ: SRDX) (before the market open)

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

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