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The Daily Biotech Pulse: Novartis Acquires Gene Therapy Company, Moderna's Japanese Vaccine Supply Deal

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The Daily Biotech Pulse: Novartis Acquires Gene Therapy Company, Moderna's Japanese Vaccine Supply Deal

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. 28)

  • Blueprint Medicines Corp (NASDAQ: BPMC)
  • Denali Therapeutics Inc (NASDAQ: DNLI)
  • Praxis Precision Medicines Inc (NASDAQ: PRAX)
  • Spruce Biosciences Inc (NASDAQ: SPRB)
  • Stoke Therapeutics Inc (NASDAQ: STOK)
  • Ultragenyx Pharmaceutical Inc (NASDAQ: RARE)
  • United Therapeutics Corporation (NASDAQ: UTHR) (reacted to it third-quarter results)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 28)

  • Acasti Pharma Inc (NASDAQ: ACST)
  • Akebia Therapeutics Inc (NASDAQ: AKBA)
  • Akerna Corp (NASDAQ: KERN) (priced its 5-million common stock offering)
  • Artelo Biosciences Inc (NASDAQ: ARTL)
  • Arvinas Inc (NASDAQ: ARVN)
  • Avenue Therapeutics Inc (NASDAQ: ATXI)
  • Baudax Bio Inc (NASDAQ: BXRX)
  • Benitec Biopharma Inc (NASDAQ: BNTC)
  • BioCardia Inc (NASDAQ: BCDA)
  • Biodesix Inc (NASDAQ: BDSX) (listed on Nasdaq Wednesday)
  • Biogen Inc (NASDAQ: BIIB)
  • Biondvax Pharmaceuticals Ltd – ADR (NASDAQ: BVXV)
  • Brickell Biotech Inc (NASDAQ: BBI)
  • Catabasis Pharmaceuticals Inc (NASDAQ: CATB)
  • Codiak BioSciences Inc (NASDAQ: CDAK)
  • Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX)
  • Cyclacel Pharmaceuticals Inc (NASDAQ: CYCC)
  • DBV Technologies ADR Representing 0.5 Ord Shs (NASDAQ: DBVT)
  • Entasis Therapeutics Holdings Inc (NASDAQ: ETTX
  • Eyepoint Pharmaceuticals Inc (NASDAQ: EYPT)
  • Foghorn Therapeutics Inc (NASDAQ: FHTX) (IPOed Friday)
  • FSD Pharma Inc (NASDAQ: HUGE)
  • Gilead Sciences, Inc. (NASDAQ: GILD)
  • Happiness Biotech Group Ltd (NASDAQ: HAPP)
  • Hoth Therapeutics Inc (NASDAQ: HOTH)
  • Immunome Inc (NASDAQ: IMNM)
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT)
  • Iterum Therapeutics PLC (NASDAQ: ITRM)
  • Jaguar Health Inc (NASDAQ: JAGX)
  • Kiromic Biopharma Inc (NASDAQ: KRBP)
  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX)
  • Liminal BioSciences Inc (NASDAQ: LMNL)
  • Metacrine Inc (NASDAQ: MTCR)
  • Neovasc Inc (NASDAQ: NVCN) (announced negative Adcom verdict for its Reducer medical device to treat refractory angina)
  • Neurobo Pharmaceuticals Inc (NASDAQ: NRBO)
  • Oncternal Therapeutics Inc (NASDAQ: ONCT)
  • Opthea Limited (NASDAQ: OPT)
  • OptiNose Inc (NASDAQ: OPTN)
  • Pandion Therapeutics Inc (NASDAQ: PAND)
  • Predictive Oncology Inc (NASDAQ: POAI)
  • ProQR Therapeutics NV (NASDAQ: PRQR)
  • Psychemedics Corp. (NASDAQ: PMD)
  • RA Medical Systems Inc (NYSE: RMED)
  • Recro Pharma Inc (NASDAQ: REPH)
  • Rockwell Medical Inc (NASDAQ: RMTI)
  • Royalty Pharma plc (NASDAQ: RPRX)
  • Satsuma Pharmaceuticals Inc (NASDAQ: STSA)
  • Silence Therapeutics ADR Representing 3 Ord Shs (NASDAQ: SLN)
  • Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS)
  • Tricida Inc (NASDAQ: TCDA)
  • X4 Pharmaceuticals Inc (NASDAQ: XFOR)
  • Zosano Pharma Corp (NASDAQ: ZSAN)

Stocks In Focus

Novartis Acquires Gene Therapy Company For Up to $280M

Novartis AG (NYSE: NVS) announced the acquisition of Vedere Bio, Inc, a stealth-stage company focused on advancing photoreceptor-protein-based optogenetic therapies that are delivered to the retina intravitreally to restore functional vision, for $150 million upfront.

Vedera is also eligible to receive up to $130 million in milestone payments, for a total of $280 million.

Takeda to Import 50M Doses of Moderna's Coronavirus Vaccine

Takeda Pharmaceutical Co Ltd (NYSE: TAK) said it will import and distribute 50 million doses of Moderna Inc's (NASDAQ: MRNA) COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan.

This effort is part of a three-way agreement among Takeda, Moderna and the Japanese government.

Previously, Takeda had agreed to manufacture and supply Novavax, Inc.'s (NASDAQ: NVAX) coronavirus vaccine in Japan.

Chemocentryx Chronic Skin Disease Drug Produces Mixed Results In a Mid-stage Study

ChemoCentryx Inc (NASDAQ: CCXI) announced topline data from its AURORA Phase 2 clinical trial of avacopan for the treatment of the chronic disabling skin disease hidradenitis suppurativa, or HS, showing the primary endpoint of the proportion of all patients, both moderate and severe patients, achieving HS clinical response after 12 weeks of treatment was not achieved with statistical significance at 10mg and 30mg twice-daily dose levels.
However, a numerical improvement was noted at the 30mg dose.

Avacopan 30mg, twice-daily dose, however, demonstrated a statistically significant higher response than placebo in the pre-specified population of severe HS patients in the study. The company said it plans to advance avacopan into Phase 3 development for the treatment of severe HS.

In after-hours trading, the stock fell 10.03% to $47.

Verastem Announces Publication of Positive Results For Early-stage Study In Mutant Cancers

Verastem Inc (NASDAQ: VSTM) announced new data published in the Lancet Oncology showed its VS-6766, when tested as both a single agent in RAS/RAF-mutant cancers such as KRAS mutant non-small cell lung cancer or in combination with small molecules including the FAK inhibitor defactinib in KRAS mutant solid tumors showed tolerability and antitumor activity in the dose-escalation study.

The company said Phase 2 registration-directed trials with VS-6766 alone and in combination with defactinib in low-grade serous ovarian cancer and KRAS mutant NSCLC are expected to commence by year-end 2020.

The stock was adding 32.17% to $1.52 in premarket trading Thursday.

Regeneron Reports Positive Results For Antibody Cocktail COVID-19 Treatment

Regeneron Pharmaceuticals Inc (NASDAQ: REGN) announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. REGN-COV2 significantly reduced viral load and patient medical visits, the company said.

The company said it has shared these results with the FDA, which is reviewing an emergency use authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes

AbbVie to Present Positive Late-stage Results For Skin Disorder Drug

AbbVie Inc (NYSE: ABBV) said it will present at the 29th European Academy of Dermatology and Venereology, or EADV, Virtual Congress, new analyses from the Phase 3 Measure Up 1 and Measure Up 2 studies, showing significantly more atopic dermatitis patients treated with upadacitinib, 15 mg or 30 mg, once daily, monotherapy achieved improvement in additional measures of skin clearance and reduction in itch compared to placebo.

These data, the company said, supports the recent applications to the FDA and EMA, seeking approval for Rinvoq in adult and adolescent patients with moderate to severe atopic dermatitis.

Earnings

Innoviva Inc's (NASDAQ: INVA) third-quarter revenues increased from $65.76 million in 2019 to $88.69 million in 2020. The earnings per share, or EPS, slid from 36 cents to 26 cents, while analysts estimated EPS of 42 cents.

The stock added 7.18% to $10 in after-hours trading.

GenMark Diagnostics, Inc (NASDAQ: GNMK) reported third-quarter revenues of $42.6 million, up 104% year-over-year. The loss per share narrowed from 20 cents to 5 cents, while the consensus had called for a loss of 6 cents per share. The company raised its full-year revenue guidance from $155 million-$165 million to $165 million-$168 million.

The stock was down 6.56% to $10.82 in after-hours trading.

Sanofi SA (NASDAQ: SNY) reported 5.7% net sales growth and a 0.5% increase in business EPS. The company upwardly revised its 2020 business EPS guidance.

Separately, Sanofi said it has entered into an agreement with Merck & Co., Inc. (NYSE: MRK) to conduct a Phase 2 clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of THOR-707, a highly differentiated non-alpha IL-2 candidate, combined with or in sequenced administration with Keytruda in patients with various cancers.

Penumbra Inc (NYSE: PEN) (after the close) reported an 8.3% year-over-year increase in third-quarter revenues to $151.1 million. The company reported non-GAAP EPS of 6 cents compared to the consensus estimate, which called for a loss of 8 cents per share.

The stock was advancing 6.57% to $248 in premarket trading Thursday.

Offering

Cancer Genetics Inc (NASDAQ: CGIX) announced an increase to the size of the previously announced public offering and purchase on a firm commitment basis 1.364 million shares of its common stock at a price of $2.20 per share, less underwriting discounts and commissions. The gross proceeds of the offering are expected to be approximately $3 million, it added.

The stock was plunging 32.94% to $2.30 in after-hours trading.

On The Radar

Clinical Readouts

Akari Therapeutics PLC (NASDAQ: AKTX) is scheduled to present at the 29th EADV Virtual Congress, safety and efficacy data from Phase 2 clinical trial of nomacopan in adults with mild to moderate in bullous pemphigoid.

At the EADV meeting, Concert Pharmaceuticals Inc (NASDAQ: CNCE) will present clinical data on CTP-543 for the treatment of alopecia areata as a late-breaker oral presentation. The presentation is scheduled between 10 am and 10:15 am.

Other Events

Tricida said it will discuss in a conference call scheduled for 8 am, its interactions with the FDA from its end-of-review Type A meeting with the Division of Cardiology and Nephrology.

Earnings

  • Evelo Biosciences Inc (NASDAQ: EVLO) (before the market open)
  • Baxter International Inc (NYSE: BAX) (before the market open)
  • Blueprint Medicines Corp (NASDAQ: BPMC) (before the market open)
  • Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) (before the market open)
  • Agenus Inc (NASDAQ: AGEN) (before the market open)
  • ABIOMED, Inc. (NASDAQ: ABMD) (before the market open)
  • Pacira Biosciences Inc (NASDAQ: PCRX) (before the market open)
  • Protalix Biotherapeutics Inc (NYSE: PLX) (before the market open)
  • Insmed Incorporated (NASDAQ: INSM) (before the market open)
  • Lexicon Pharma (before thee market open)
  • Moderna Inc (before the market open)
  • Novocure Ltd (NASDAQ: NVCR) (before the market open)
  • Syneos Health Inc (NASDAQ: SYNH) (before the market open)
  • Xtant Medical Holdings Inc (NYSE: XTNT) (before the market open)
  • Constellation Pharmaceuticals Inc (NASDAQ: CNST) (before the market open)
  • Alkermes Plc (NASDAQ: ALKS) (before the market open)
  • AxoGen, Inc Common Stock (NASDAQ: AXGN) (after the close)
  • BioTelemetry Inc (NASDAQ: BEAT) (after the close)
  • PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close)
  • Illumina, Inc. (NASDAQ: ILMN) (after the close)
  • Natus Medical Inc (NASDAQ: NTUS) (after the close)
  • LeMaitre Vascular Inc (NASDAQ: LMAT) (after the close)
  • ResMed Inc. (NYSE: RMD) (after the close)
  • NuVasive, Inc. (NASDAQ: NUVA) (after the close)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close)
  • Opko Health Inc. (NASDAQ: OPK) (after the close)
  • Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE: BIO) (after the close)
  • Quidel Corporation (NASDAQ: QDEL) (after the close)
  • EXACT Sciences Corporation (NASDAQ: EXAS) (after the close)
  • Cerus Corporation (NASDAQ: CERS) (after the close)
  • CareDx Inc (NASDAQ: CDNA) (after the close)
  • KemPharm Inc (OTC: KMPH)
  • Strongbridge Biopharma plc (NASDAQ: SBBP)
  • Genocea Biosciences Inc (NASDAQ: GNCA)

IPOs

Galecto, Inc., a Wilmington, Delaware-based clinical-stage biotech company developing therapeutics for fibrosis, priced its 5.67-million-stock initial public offering at $15 per share compared to the estimated price range of $14-$16. The company's shares will begin trading on the Nasdaq under the ticker symbol GLTO. Gross proceeds from the offering is expected at $85 million.

 

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