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Sarepta Therapeutics Inc. ($SRPT) stock stumbled as the company grappled with the consequences of failing reimbursement issues related to Exondys 51. There had been several analyst reports circulating that the reimbursement situation related to this Duchenne muscular dystrophy (DMD) med is dire. The company may face problems with convincing insurers to cover the expenses related to this drug.
According to a survey conducted by Leerink, the scenario is quite bleak for the company. Sarepta had previously stated the vast majority of patients that require treatment will indeed receive therapy this year. However, it seems that payors are declining the coverage at alarming rate.
The company stock is up 6 percent this year so far. Its 12 months gain stands at over 144 percent. The new controversy may have slight negative impact on the company’s stock price.

Lannett Company Inc. ($LCI) reported better than expected results for the second quarter of the year. Its net income for the quarter stood at $8.2 million or $0.92 per share, exceeding the street estimates of $0.83 per share. The company’s revenue was reported at $170.9 million, surpassing estimates of $168.9 million in revenue. Lannett expects its full-year revenue to be in the range of $675 million to $685 million.
The company stock has lost 6 percent of its value this year so far while its 12 months loss is close to 19 percent. It recently announced the voluntary payment of $75 million to reduce its revolving credit facility. The company CEO stated that the payment is consistent with the company’s commitment to reduce debt. The debt reduction will save the company approximately $4.1 million in annualized cash interest expense, at current rates.

 

• Forward Pharma ($FWP) announced that its shareholders have voted in favor of the proposed $1.25B settlement with Biogen ($BIIB) related to a patent covering methods of treating multiple sclerosis with 480 mg of dimethyl fumarate (DMF), the active ingredient in Biogen's top selling Tecfidera. Forward is entitled to receive the payment within five business days.
• Kitov Pharmaceuticals ($KTOV) announced that the USPTO has issued a Notice of Allowance to the company for an additional patent covering lead product candidate KIT-302, specifically covering oral dosage compositions containing both amlodipine and celecoxib. The company expects its U.S. marketing application for KIT-302 to be completed this quarter.

• Sanofi ($SNY) reported that the FDA has approved its Xyzal Allergy 24HR, an over-the-counter treatment for allergy symptoms. The product will be marketed by the company's Consumer Healthcare unit and is expected to be released in the coming months.
• Abbott ($ABT) announced that the FDA has approved its Assurity MRI pacemaker and the Tendril MRI pacing lead. The company claims it is the world's smallest, longest-lasting wireless MRI-compatible pacer. Patients implanted with the device have the ability to undergo a full-body MRI scan, if required. It also features wireless remote monitoring which provides doctors secure access to patients' diagnostic data and daily device measurements, reducing the need for in-office visits.

 
• Vericel ($VCEL) reported that it has implanted its first patient in the U.S. with MACI (autologous cultured chondrocytes on porcine collagen membrane), a cellular scaffold product indicated to the repair of cartilage defects in the knee with or without bone involvement. It is the first product that uses the process of tissue engineering to grow cartilage cells on a scaffold to gain FDA approval.
• BioMarin Pharmaceutical's ($BMRN) announced that its gene therapy candidate for hemophilia A, BMN-270 has been granted access to the Priority Medicines (PRIME) regulatory initiative by The European Medicines Agency.

 
• AstraZeneca PLC ($AZN) reported 13 percent drop in its fourth quarter revenue after the cholesterol treatment Crestor lost patent protection in the United States. Total revenue dropped to $5.59 billion from $6.40 billion in the same period a year earlier. Crestor sales fell 52 percent to $631 million as generic competitors ate into its market share. The company’s net income rose to $1.84 billion from $808 million.
• Parexel International Corp ($PRXL) reported its fiscal second-quarter net income at $21.8 million. Its adjusted earnings for the quarter stood at $0.85 per share, beating the consensus estimate of $0.83 per share. The company reported revenue of $612.2 million in the period. Its adjusted revenue was $534.4 million, which missed Street forecasts of $537.4 million. For the current quarter ending in April, the company expects its per-share earnings to range from $0.66 to $0.80. It expects the revenue in the range of $524 million to $538 million for the fiscal third quarter. The estimate for full-year earnings is in the range of $3.15 to $3.43 per share.

• Dimension Therapeutics ($DMTX) received Buy rating from Jefferies. The price target for the stock has been set at $7 apiece.
• Kadmon Holdings ($KDMN) received Buy rating from H.C. Wainwright. The price target for the stock has been set at $25 apiece.

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