The Daily Biotech Pulse: Akebia Sues CMS, Roche Raises Guidance Yet Again, Titan Medical Entangled In Credit Crunch

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. 15)

• Celgene Corporation CELG
• Eagle Pharmaceuticals Inc EGRX
• Kodiak Sciences Inc KOD
• The Medicines Company MDCO
• Natera Inc NTRA
• Ra Pharmaceuticals Inc RARX
• Reata Pharmaceuticals Inc RETA (announced positive results for a Phase 2 study of its drug to treat Friedreich ataxia)
• Relmada Therapeutics Inc RLMD ( announced positive Phase 2 results for drug to treat treatment-resistant depression)
• Zoetis Inc ZTS

Down In The Dumps

(Biotech stocks hitting 52-week lows on Oct. 15)

• Auris Medical Holding Ltd EARS
• BENITEC BIOPHAR/S ADR BNTC
• Chimerix Inc CMRX
• Cleveland BioLabs, Inc. CBLI
• Fulcrum Therapeutics Inc FULC
• Heat Biologics Inc HTBX
• INmune Bio Inc INMB
• Kaleido Biosciences Inc KLDO
• Karuna Therapeutics Inc KRTX
• Mirum Pharmaceuticals Inc MIRM
• Novus Therapeutics Inc NVUS
• Orgenesis Inc ORGS
• Phio Pharmaceuticals Corp PHIO
• Precision BioSciences Inc DTIL
• Pulmatrix Inc PULM
• Sierra Oncology Inc SRRA
• Strongbridge Biopharma plc SBBP

Stocks In Focus

Akebia Sues CMS For Restoring Coverage For Kidney-Disease Related Anemia Drug

Akebia Therapeutics Inc AKBA has filed a compliant in federal district court against the Centers of Medicare & Medicaid Service and the U.S. Department of Health and Human Services challenging a September 2018 decision by CMS that cancelled Medicare Part D coverage of Auryxia, its drug for treating iron deficiency anemia in adult patients with chronic kidney disease.

Through the lawsuit the company said it seeking restoration of coverage of Auryxia for the indication and removal of prior authorization requirement for the hyperphosphatemia indication.

The stock moved down 3.70% to $4.16 in after-hours trading.

Roche Nine-Month Sales Rise 10%; Raises Full-Year Sales Guidance

Roche Holdings AG Basel ADR RHHBY reported a 10% group sales growth for the nine-months ended Sept. 30, at constant exchange rate, with Pharma division's sales rising 12% and diagnostic division's sale climbing 4%.

The company raised its full-year sales growth outlook to high-single digit range, and guided to core earnings per share growth to be broadly in line with sales growth at constant exchange rates.

Titan Medical Refiles Preliminary Prospectus; Withdraws Previously Published Milestones

Titan Medical Inc. TMDI has filed an amended and restated preliminary short form prospectus with the securities regulators in the provinces of Ontario, British Columbia and Alberta, and also filed a corresponding registration statement on Form F-10 with the SEC. The filings are related to the proposed marketed offering of units for a total gross proceeds of $15 million to $25 million.

The company also said it is withdrawing all forward-looking statements, included in its continuous disclosure documents with respect to the cost and timing of development of its robotic surgical system beyond the fourth quarter of 2019. The company attributed the action to a lack of financing, which has caused its primary product development supplier to limit the development work on the robotic surgical system.

The stock plunged 53.27% to 50 cents in after-hours trading.

Aquestive Reaffirms Guidance After Partner Indivior Opts To Cease Production of Opioid Addiction Drug

Aquestive Therapeutics Inc AQST reaffirmed its full-year 2019 revenue guidance in the wake of partner INDIVIOR PLC/S ADR INVVY announcing its intent to cease production of its authorized generic buprenorphine-naloxone film product. The company now expects total revenue to come in at the high-end of the guidance range of $38 million to $45 million.

Aquestive expects revenue from its Suboxone franchise, comprising Suboxone and the authorized generic buprenorphine-naloxone film product, to be at the top-end of the $29 million to $32 million guidance range.

ProQR Gets Rare Pediatric Disease Designation For Sepofarsen, to Offer $5M Worth of Shares

ProQR Therapeutics NV PRQR has received Rare Pediatric Disease, or RPD designation from the FDA for sepofarsen in treating Leber's congenital amaurosis 10, which leads to blindness due to genetic disease in children.

The company also announced plans to offer $5 million worth of shares in an underwritten public offering.

The stock slipped 11.58% to $5.50 in after-hours trading.

Offerings

Rhythm Pharmaceuticals Inc RYTM priced its public offering of 8.11 million shares at $18.50 per share. All the shares are being offered by the company. The company expects the offering to close on Oct. 18.

The stock slipped 11.35% to $18.52 in after-hours trading.

Natera launched a follow-on offering of $175 million worth of its common stock. The company cautioned that the offering is subject to market and other conditions, and that there can be no assurance as to whether and when the offering may be completed or regarding the size or terms of the offering.

The stock lost 5.92% to $36.90 in after-hours trading.

Principia Biopharma Inc PRNB priced its 7.5 million follow-on common stock offering at $28 per share. The company expects to mobilize gross proceeds of about $210 million from the offering. All the shares earmarked for the offering are to be offered by the company. The offering is expected to close on Oct. 18.

The stock fell 3.01% to $29.01 in after-hours trading.

On The Radar

Clinical Trial Readouts

Marinus Pharmaceuticals Inc MRNS will present at the Neurocritical Care Society Meeting already-released Phase 2 data for ganaxolone in refractory status epilepticus.

Myovant Sciences Ltd MYOV will present at the American Society for Reproductive Medicine 2019 meeting, Phase 3 data for relugolix from the LIBERTY1 and LIBERTY 2 trials. Relugolix is being evaluated for menstrual bleeding associated with uterine fibroids.

Earnings

Abbott Laboratories ABT (before the market open)