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

Down In The Dumps

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

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

Stocks In Focus

Novartis Acquires Gene Therapy Company For Up to $280M

Novartis AG 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 TAK said it will import and distribute 50 million doses of Moderna Inc's 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 NVAX coronavirus vaccine in Japan.

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

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