The Daily Biotech Pulse: FDA Approves Novartis Lung Cancer Drug, 2-Way Contest Emerging For Tetraphase Pharma, Dexcom To Join S&P 500

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 May 6.)

• Adverum Biotechnologies Inc ADVM
• Alnylam Pharmaceuticals, Inc. ALNY (reacted to its first-quarter results and clinical pipeline update)
• AstraZeneca plc AZN (announced FDA approval for label expansion for its Farxiga)
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• BIO-TECHNE Corp TECH
• Catalent Inc CTLT
• Cytosorbents Corp CTSO (reacted to its strong first-quarter results)
• DexCom, Inc. DXCM
• GENMAB A/S/S ADR GMAB (announced first-quarter results)
• Horizon Therapeutics PLC HZNP (reacted to first-quarter results)
• Imara Inc IMRA
• Immunomedics, Inc. IMMU
• Immunovant Inc IMVT
• Kala Pharmaceuticals Inc KALA
• MacroGenics Inc MGNX (reacted to its first-quarter results and sell-side reactions to the results)
• Masimo Corporation MASI
• Meridian Bioscience, Inc. VIVO (announced partnership with QuantuMDx on its SARS-CoV-2 assay for laboratory use)
• ORIC Pharmaceuticals Inc ORIC
• OraSure Technologies, Inc. OSUR
• Quidel Corporation QDEL
• Repligen Corporation RGEN (reacted to its first-quarter results)
• TG Therapeutics Inc common stock TGTX (announced raising of $60 million in an at-the-market offering)
• Twist Bioscience Corp TWST (announced identification of antibodies against SARS-CoV-2 that could help develop diagnostic tests/therapies)
• Vascular Biogenics Ltd VBLT

Down In The Dumps

(Biotech stocks hitting 52-week lows May 6.)

• Apyx Medical Corp APYX
• Biofrontera AG BFRA
• Lyra Therapeutics Inc LYRA (went public May 1)
• Sonnet Biotherapeutics Holdings Inc SONN

Stocks In Focus

Novartis Secures FDA Nod For Lung Cancer Drug In Patients With Certain Mutations

Novartis AG NVS announced FDA approval for Tabrecta, an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test.

The company said continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The FDA also approved FoundationOne CDx as the companion diagnostic for Tabrecta, to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue, Novartis said. 

Novartis licensed the drug from Incyte Corporation INCY under a 2008 agreement.

Novartis shares were down 0.28% at $85.11 in the premarket session Thursday.

La Jolla Jumps Into The Fray To Buy Tetraphase Pharma

La Jolla Pharmaceutical Company LJPC said in a SEC filing that it submitted a non-binding offer to acquire 100% of the equity of Tetraphase Pharmaceuticals Inc TTPH in an all-cash transaction. La Jolla offered $22 million in cash, plus an additional $12.5 million potentially payable under contingent value rights to be issued in the transaction.

Tetraphase meanwhile has signed a definitive agreement to be bought by AcelRx Pharmaceuticals Inc ACRX in a stock-for-stock deal at an exchange ratio of 0.6303 shares of AcelRx for each share of Tetraphase, or approximately $14.4 million as of the close of trading on March 13, 2020, plus a CVR.

In premarket trading, Tetraphase was rallying 49.82% to $2.03, La Jolla was slipping 1.91% to $7.69, while AcelRx was advancing 8.97% to $1.58.

See also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates

PTC To Buy Censa Pharma

PTC Therapeutics, Inc. PTCT announced an agreement to acquire Censa Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of CNSA-001, for an upfront cash payment of $10 million and up to 850,000 shares of PTC common stock.

PTC is also liable to pay potential future considerations, including $217.5 million in development and regulatory milestones, $109 million in development and regulatory milestones for each additional indication of CNSA-001, net sales milestones up to an aggregate amount of $160 million and a contingent value payment of a percentage of annual net sales ranging from single to low double digits.

CNSA-001 is a clinical-stage investigational therapy for orphan metabolic diseases, including phenylketonuria and other diseases associated with defects in the tetrahydrobiopterin biochemical pathways diagnosed at birth.

The transaction was approved by the boards of both companies, according to PTC. The companies expect the deal to close in the second quarter.

BioNTech Closes Neon Therapeutics Acquisition

BioNTech SE – ADR BNTX, which is partnering with Pfizer Inc. PFE on a coronavirus vaccine program, announced the closing of its previously announced acquisition of Neon Therapeutics through an all-stock transaction.

The new subsidiary based in Cambridge, Massachusetts, will operate under the name of BioNTech US Inc. and serve as BioNTech's U.S. headquarters.

In premarket trading Thursday, BioNTech shares were adding 2.55% to $49.

Dexcom To Replace Allergan In The S&P 500 Index

Dexcom is to join the S&P 500 Index prior to the market open May 12, replacing Allergan plc AGN, which is to be acquired by AbbVie Inc ABBV, S&P said in a release.

Dexcom was seen adding 4.79% to $384.09 in premarket trading Thursday.

Erytech Says Clinical Program On Track

Offering a clinical pipeline update, Erytech Pharma SA ERYP said more than 75% of patients have been enrolled in the TRYbeCA-1 Phase 3 trial that is evaluating its eryapase in second-line metastatic pancreatic cancer.

The company expects to report the results of the interim superiority analysis around the end of 2020 and the final result in the second half of 2021. The investigational asset has been given Fast Track designation by the FDA for the indication.

Following a safety review by an, independent data monitoring committee, Erytech said it has been given the go-ahead to proceed. As of March 31, the company had cash and cash equivalents totaling about $64.6 million.

The stock was rallying 8.24% to $10.51 in premarket trading. 

Offerings

GenMark Diagnostics, Inc GNMK priced its previously announced underwritten public offering of 7.25 million shares at $9.65 per share, to generate gross proceeds of about $70 million. The offering is expected to close on or about May 11.

In premarket trading Thursday, the stock was edging up 0.41% to $9.75.

Chembio Diagnostics Inc CEMI announced a proposed public offering of an undetermined number of shares of its common stock. All shares are to be offered by Chembio.

The stock was falling by 0.48% to $12.55 in premarket trading.

Earnings

ADMA Biologics Inc's ADMA first-quarter revenues nearly doubled to $10.2 million and the net loss per share narrowed from 28 cents to 26 cents. The results trailed expectations.

The company had had cash and cash equivalents of $101.2 million as of March 31.

The stock declined was down 8.44% at $2.93 in the premarket session. 

Opko Health Inc. OPK reported a decline in its first-quarter revenues from $225.9 million in 2019 to $211.5 million in 2020. The net loss narrowed from 14 cents per share to 9 cents per share. The revenues missed expectations, while the loss per share was in line.

The stock was down 4.27% at $2.24 in the premarket session.

On The Radar

Earnings

• Selecta Biosciences Inc SELB (before the market open)
• Autolus Therapeutics Ltd – ADR AUTL (before the market open)
• Urogen Pharma Ltd URGN (before the market open)
• VolitionRX Ltd VNRX (before the market open)
• Orchard Therapeutics PLC – ADR ORTX (before the market open)
• Oncternal Therapeutics Inc ONCT (before the market open)
• Integra Lifesciences Holdings Corp IART (before the market open)
• Intra-Cellular Therapies Inc ITCI (before the market open)
• Endo International PLC ENDP (before the market open)
• Xeris Pharmaceuticals Inc XERS (before the market open)
• Moderna Inc MRNA (before the market open)
• Syros Pharmaceuticals Inc SYRS (before the market open)
• Elanco Animal Health Inc ELAN (before the market open)
• Athenex Inc ATNX (before the market open)
• Aldeyra Therapeutics Inc ALDX (before the market open)
• Albireo Pharma Inc ALBO (before the market open)
• ANI Pharmaceuticals Inc Common Stock ANIP (before the market open)
• Agenus Inc AGEN (before the market open)
• Amicus Therapeutics, Inc. FOLD (before the market open)
• Brainstorm Cell Therapeutics Inc BCLI (before the market open)
• Bristol-Myers Squibb Co BMY (before the market open)
• Progenics Pharmaceuticals, Inc. PGNX (before the market open)
• X4 Pharmaceuticals Inc XFOR (before the market open)
• Miragen Therapeutics Inc MGEN (before the market open)
• Kala Pharmaceuticals Inc KALA (before the market open)
• Seres Therapeutics Inc MCRB (before the market open)
• Intellia Therapeutics Inc NTLA (before the market open)
• Momenta Pharmaceuticals, Inc. MNTA (before the market open)
• Editas Medicine Inc EDIT (before the market open)
• Pacira Biosciences Inc PCRX (before the market open)
• Syndax Pharmaceuticals Inc SNDX (after the close)
• Tricida Inc TCDA (after the close)
• Helius Medical Technologies Inc HSDT (after the close)
• Twist Bioscience Corp TWST (after the close)
• Athersys Inc ATHX (after the close)
• Accelerate Diagnostics Inc AXDX (after the close)
• Adamas Pharmaceuticals Inc ADMS (after the close)
• Arena Pharmaceuticals, Inc. ARNA (after the close)
• Anika Therapeutics Inc ANIK (after the close)
• Arrowhead Pharmaceuticals Inc ARWR (after the close)
• ACADIA Pharmaceuticals Inc. ACAD (after the close)
• Calithera Biosciences Inc CALA (after the close)
• BioDelivery Sciences International, Inc. BDSI (after the close)
• Puma Biotechnology Inc PBYI (after the close)
• Coherus Biosciences Inc CHRS (after the close)
• Kindred Biosciences Inc KIN (after the close)
• PDL BioPharma Inc PDLI (after the close)
• Rockwell Medical Inc RMTI (after the close)
• Penumbra Inc PEN (after the close)
• Pfenex Inc PFNX (after the close)
• ZIOPHARM Oncology Inc. ZIOP (after the close)
• NovaBay Pharmaceuticals, Inc. NBY (after the close)
• ICU Medical Inc ICUI (after the close)
• Nektar Therapeutics NKTR (after the close)
• Savara Inc SVRA (after the close)
• Sunesis Pharmaceuticals, Inc. SNSS (after the close)
• OptiNose Inc OPTN (after the close)
• Eloxx Pharmaceuticals Inc ELOX (after the close)
• Five Prime Therapeutics Inc FPRX (after the close)
• Flexion Therapeutics Inc FLXN (after the close)
• FibroGen Inc FGEN (after the close)
• Globus Medical Inc GMED (after the close)
• Guardant Health Inc GH (after the close)
• OpGen Inc OPGN (after the close)
• Lineage Cell Therapeutics Inc LCTX (after the close)
• Dynavax Technologies Corporation DVAX (after the close)
• Chiasma Inc CHMA (after the close)
• Collegium Pharmaceutical Inc COLL (after the close)
• Dicerna Pharmaceuticals Inc DRNA (after the close)
• Caladrius Biosciences Inc CLBS (after the close)
• Glaukos Corp GKOS (after the close)
• Celcuity Inc CELC (after the close)
• Codexis, Inc. CDXS (after the close)
• CytomX Therapeutics Inc CTMX (after the close)
• Insulet Corporation PODD (after the close)  
• Anavex Life Sciences Corp AVXL (after the close)
• Arcturus Therapeutics Ltd ARCT (after the close)
• SAGE Therapeutics Inc SAGE (after the close)
• Revance Therapeutics Inc RVNC (after the close)
• Xencor Inc XNCR (after the close)
• Protagonist Therapeutics Inc PTGX (after the close)
• Regenxbio Inc RGNX (after the close)
• Provention Bio Inc PRVB (after the close)

Related Link: The Week Ahead In Biotech: Smid-Cap Earnings News Flow Picks Up Pace