The Daily Biotech Pulse: KemPharm, FDA Nod For Merck, Clovis Q3 Miss, 3 Stocks To Debut

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peak

(Biotech stocks hitting 52-week highs on Oct. 30)

• Gamida Cell Ltd GMDA
• NeoGenomics, Inc. NEO

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 30)

• Adamas Pharmaceuticals Inc ADMS
• Alpine Immune Sciences Inc ALPN
• Athenex Inc ATNX
• Biocept Inc BIOC
• BIOLINERX Ltd/S ADR BLRX
• BioSig Technologies Inc BSGM
• Bio-Path Holdings Inc BPTH
• Celldex Therapeutics, Inc. CLDX
• Dova Pharmaceuticals Inc DOVA
• Dynavax Technologies Corporation DVAX
• Eagle Pharmaceuticals Inc EGRX
• FibroGen Inc FGEN
• Insmed Incorporated INSM(reported a wider loss for its Q3)
• IntelliPharmaCeutics Intl Inc IPCI
• Jounce Therapeutics Inc JNCE
• Kala Pharmaceuticals Inc KALA
• Leap Therapeutics Inc LPTX
• Neos Therapeutics Inc NEOS
• Neuralstem, Inc. CUR
• OpGen Inc OPGN
• Ovid Therapeutics Inc OVID
• Pieris Pharmaceuticals Inc PIRS
• RA Medical Systems Inc RMED
• Selecta Biosciences Inc SELB
• The Medicines Company MDCO
• VBI Vaccines Inc VBIV
• Zosano Pharma Corp ZSAN

Stocks In Focus

FDA Approves Merck's Keytruda-Chemotherapy Combo For Lung Cancer

Merck & Co., Inc. MRK said the FDA approved its anti-PD-1 therapy Keytruda, in combination with carboplatin and either paclitaxel or nab-paclitaxel, for the first-line treatment of patients with metastatic squamous non-small cell lung cancer. The approval was based on the results from the Phase 3 KEYNOTE-407 trial.

Kindred's Pet Skin Disorder Drug Found Effective In Trial

Kindred Biosciences Inc KIN announced positive top-line results for its pilot effectiveness study of KIND-016, which is being tested for atopic dermatitis in dogs. The company estimates the market size for the drug to be over $500 million annually.

The stock rose 15.35 percent to $14.20 in after-hours trading.

See Also: The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trial Results, Earnings And IPOs

KemPharm Grants U.S. Commercial Rights For Pain Drug To KVK Tech

KemPharm Inc KMPH announced a collaboration and license agreement under which it will grant the U.S. commercial rights of its FDA-approved prodrug Apadaz to KVK Tech. The agreement provides for KemPharm receiving an estimated $3.4 million in pre-launch payments, as well as an aggregate of up to $53 million in milestone payments tied to specific net sales levels.

Apadaz is a prescription opioid for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The stock rallied 14.22 percent to $2.49 in after-hours trading.

Actinium To Add Two Key Initiatives For Blood Disorder Drug Following Positive FDA Discussions

Following the successful completion of the Actimab-A phase 2 trial of its CD33 antibody radiation conjugate, or ARC, in acute myeloid leukemia, or AML, Actinium Pharmaceuticals Inc ATNM said it will initiate a pivotal trial for myelodysplastic syndromes, or MDS, and a combination trial with Venetoclax for AML.

The company said it has had positive discussions with the FDA for the Actimab-MDS program, which has facilitated an accelerated pathway to a pivotal trial after a short dose finding Phase 1 portion.

The stock gained 9.84 percent to $0.67 in after-hours trading.

Earnings

Amgen, Inc. AMGN reported 2 percent revenue growth for Q3, with product sales rising a mere 1 percent. Non-GAAP EPS rose 13 percent to $3.69. The results exceeded expectations. The company also raised its full-year guidance.

The stock slipped 0.49 percent to $188.15 in after-hours trading.

EXACT Sciences Corporation EXAS reported 63 percent revenue growth to $118.3 million, as Cologuard test volume increased 49 percent to 241,000. The net loss widened to 37 cents per share from 23 cents per share last year, while the consensus had called for a loss of 43 cents per share. The company also raised its FY18 revenue guidance.

The stock advanced 8.56 percent to $69.91 in after-hours trading.

Clovis Oncology Inc CLVS reported Q3 product revenues of $22.76 million compared to $16.806 million last year. The company's net loss widened from $1.24 to $1.71.

The results trailed expectations.

"Based on current trends in PARP inhibitor adoption, the Company anticipates Q4 2018 revenues to be consistent with or slightly higher than Q3 2018 reported revenues of $22.8 million," the company said. This is below the consensus estimate of $29.19 million.

The stock slumped 19.69 percent to $13.34 in after-hours trading.

BioTelemetry Inc BEAT reported better-than-expected third-quarter results and raised its full-year revenue guidance.

The stock rose 9.87 percent to $56 in after-hours trading.

Sanofi SA SNY reported better-than-expected third quarter earnings, propped up by its vaccines business and its Genzyme unit. The company narrowed its full-year earnings per share growth guidance from 3-5 percent to 4-5 percent.

Separately, the company said the FDA has accepted the BLA for its dengue vaccine with priority review status. The PDUFA date has been set for May 1, 2019.

On The Radar

Earnings

Acorda Therapeutics Inc ACOR Q3 Adj. EPS $0.17 Beats $(0.02) Estimate, Sales $142.814M Beat $82.81M Estimate
ArQule, Inc. ARQL Q3 EPS $(0.05) Beats $(0.06) Estimate, Sales $4.979M Beat $2.26M Estimate
Integra Lifesciences Holdings Corp IART Q3 Adj. EPS $0.59, Inline, Sales $365.9M Miss $370.41M Estimate
Intercept Pharmaceuticals Inc ICPT Q3 EPS $(2.18) Beats $(2.55) Estimate, Sales $46.986M Miss $48.46M Estimate
Ophthotech Corp OPHT Q3 EPS $(0.41) Beats $(0.43) Estimate
United Therapeutics Corporation UTHR Q3 Adj. EPS $3.98 Beats $3.15 Estimate, Sales $412.7M Beat $381.27M Estimate
Orthopediatrics Corp KIDS (after the market close)
CAS Medical Systems Inc CASM

IPO

Medical device maker Axonics Modulation Technologies priced its upsized offering of 8 million shares at $15, the mid-point of the estimated price range of $14-$16. The shares are to be listed on the Nasdaq under the ticker symbol AXNX.

Twist Bioscience, a manufacturer of synthetic genes and other DNA-based products, priced its 5-million share IPO at $14, the lower end of the estimated price range of $14-$16. The shares will be listed on the Nasdaq under the ticker symbol TWST.

Orchard Therapeutics priced its 14.286-million share IPO at $14 compared to the estimated price range of $14-$16. The shares of the developer of stem cell gene therapies to treat rare diseases, will be listed on the Nasdaq under the ticker symbol ORTX.