The Daily Biotech Pulse: Illumina's Strong Q3, Celgene's Positive Cancer Drug Trial, Proteostasis Offering

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 on Oct. 23)

• Amarin Corporation plc AMRN
• Imprimis Pharmaceuticals Inc IMMY

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 23)

• AbbVie Inc ABBV(reported its Upadacitinib showed significant improvements in physical function, pain and quality of life as a monotherapy in patients with rheumatoid arthritis in a late-stage study)
• Bristol-Myers Squibb Co BMY
• Advaxis, Inc. ADXS
• Aerpio Pharmaceuticals Inc ARPO
• Aravive Inc ARAV
• Capricor Therapeutics Inc CAPR
• Cleveland BioLabs, Inc. CBLI
• Clovis Oncology Inc CLVS
• CytomX Therapeutics Inc CTMX
• CytRx Corporation CYTR
• Endologix, Inc. ELGX
• Erytech Pharma SA ERYP
• Evelo Biosciences Inc EVLO
• Genprex Inc GNPX
• Jounce Therapeutics Inc JNCE
• LogicBio Therapeutics Inc LOGC
• Melinta Therapeutics Inc MLNT
• Mersana Therapeutics Inc MRS
• Mustang Bio Inc MBIO
• NewLink Genetics Corp NLNK
• Paratek Pharmaceuticals Inc PRTK
• Provention Bio Inc PRVB
• SCYNEXIS Inc SCYX
• Translate Bio Inc TBIO

Stocks In Focus

Clementia to Submit NDA For Bone Disorder Drug Following Meeting With FDA

Following Clementia Pharmaceuticals Inc CMTA's interactions with the FDA, which includes a Type B meeting held Tuesday, the company said the FDA has deemed that the available data supports an NDA filing for palovarotene for the prevention of heterotopic ossification, or HO, associated with flare up symptoms in patients with fibrodysplasia ossifications progressiva, or FOP.

The company clarified that FDA's assessment was based on efficacy and safety data from the completed Phase 2 trial that showed a statistically significant reduction in new HO volume, or bone volume, associated with flare-ups of FOP at 12 weeks as compared to placebo or untreated flare ups.

Clementia said it plans to submit an NDA for palovarotene to the FDA.

The stock jumped 35.88 percent to $14.05 in after-hours trading.

Celgene's Cancer Drug Found Safe, Effective Against Asymptomatic Smoldering Multiple Myeloma

Celgene Corporation CELG released results of a Phase 2/3 study dubbed ECOG E3A06, which evaluated the safety and efficacy of Revlimid monotherapy in patients with asymptomatic smoldering multiple myeloma, which showed that the drug achieved statistically significant improvement in the primary endpoint of progression-free survival compared to observation.

Varian Inks Deal to Supply Linear Accelerators and Treatment Planning Software

Varian Medical Systems, Inc. VAR announced an agreement with cancer care treatment provider GenesisCare for providing 70 Varian linear accelerators and Varian Eclipse treatment planning software in a bid to increase access to cancer care in Australia, the U.K. and Spain. The agreement also provides for Varian supporting skin cancer clinical trials using Varian RapidArc tech and the development of software for the emerging field of theranostics.

Varian stock rose 4.48 percent to $109 in after-hours trading.

See Also: Neovasc Broadcasts Surgery With Mitral Valve Device Live At Medical Conference

Earnings

Edwards Lifesciences Corp EW reported Q3 sales of $907 million, up 10 percent year-over-year, and adjusted EPS rose 27 percent to $1.07, ahead of the $1.02 consensus estimate. The company expects 2018 sales to come in at the high-end of its guidance range of $3.5 billion to $3.9 billion, while it continues to expect adjusted EPS of $4.60-$4.75. The guidance is in line with estimates.

The stock fell 2.9 percent to $144 in after-hours trading.

Illumina, Inc. ILMN reported Q3 revenues of $853 million, up 20 percent, and non-GAAP EPS of $1.52 versus $1.11 a year-ago and the $1.26 consensus estimate. For 2018, the company expects revenue growth of 20 percent and non-GAAP EPS of $5.70-$5.75. The revenue guidance is in line, while the EPS guidance exceeded estimates.

The stock fell 0.57 percent to $312 in after-hours trading.

Pricing Of Offerings

Proteostasis Therapeutics Inc PTI priced its previously announced underwritten public offering of 11 million shares at $6.75 per share. The offering is expected to generate gross proceeds of $74.3 million.

Krystal Biotech Inc KRYS announced the closing of its previously announced underwritten public offering of 3 million shares at $20 per share. The gross proceeds from the public offering were $69 million.

On The Radar

Earnings

• Alexion Pharmaceuticals, Inc. ALXN Q3 EPS $2.02 Beats $1.74 Estimate, Sales $1.027B Beat $1.02B Estimate
• Boston Scientific Corporation BSX Q3 EPS $0.35 Beats $0.34 Estimate, Sales $2.393B Miss $2.4B Estimate
• Anika Therapeutics Inc ANIK (after the market close)
• La Jolla Pharmaceutical Company LJPC (after the market close)
• Sarepta Therapeutics Inc SRPT (after the market close)
• Vertex Pharmaceuticals Incorporated VRTX (after the market close)

Clinical Trial Results

TrovaGene Inc TROV will release Phase 1/2 data for its Onvansertib and Zytiga combo that is being evaluated for prostate cancer. The company will also release updated Phase 1/2 data for Onvansertib monotherapy in treating acute myeloid leukemia.